Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-18 @ 8:30 AM
Study NCT ID:
NCT02445456
Status:
TERMINATED
Last Update Posted:
2022-07-06
First Post:
2015-05-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'helen.jones3@ouh.nhs.uk', 'phone': '01865 235657', 'title': 'Miss Helen Jones', 'organization': 'Oxford University Hospitals NHS Foundation Trust'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over the time between tracer injection until discharge from hospital after surgery. The range was 9-77 days due to differences in patient pathways.', 'eventGroups': [{'id': 'EG000', 'title': 'Ex-vivo', 'description': 'Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'In-vivo', 'description': 'Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Post-operative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing of Adverse or Hypersensitivity Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ex-vivo', 'description': 'Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}, {'id': 'OG001', 'title': 'In-vivo', 'description': 'Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 days after injection', 'description': 'Assess frequency of any adverse of hypersensitivity reactions to tracer after endoscopic injection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Operations Where Effects of Tracer Injection Can be Detected by Surgeon During Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Operations', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ex-vivo', 'description': 'Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}, {'id': 'OG001', 'title': 'In-vivo', 'description': 'Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at time of surgery', 'description': 'Assess frequency of Sienna+ tracer being detectable at the tumour injection site and in the lymph nodes at the time of surgery', 'unitOfMeasure': 'operations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Operations', 'denomUnitsSelected': 'Operations', 'populationDescription': "Only patients who underwent surgery were analysed. Two patients in the ex-vivo group who were planned to have surgery did not proceed to surgery; instead they moved to a 'watch and wait' pathway after chemoradiation."}, {'type': 'PRIMARY', 'title': 'Number of Operations Where There Was Any Surgical Difficulty Due to Tracer Injection Based on Qualitative Assessment by Surgeon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'Operations', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ex-vivo', 'description': 'Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}, {'id': 'OG001', 'title': 'In-vivo', 'description': 'Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at time of surgery', 'description': "Surgeon's qualitative assessment of any difficulties encountered during surgery which could be attributable to prior injection of the tracer, such as pigmentation or fibrosis making surgery more difficult than normal", 'unitOfMeasure': 'operations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Operations', 'denomUnitsSelected': 'Operations', 'populationDescription': "Only patients who underwent surgery were analysed. Two patients in the ex-vivo group who were planned to have surgery did not proceed to surgery; instead they moved to a 'watch and wait' pathway after chemoradiation."}, {'type': 'SECONDARY', 'title': 'Number of Mesorectal Specimens Which Demonstrated Correlation Between Histopathology and Sentimag Probe Findings for Lymph Node Number and Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'Surgical mesorectal specimens', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ex-vivo', 'description': 'Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}, {'id': 'OG001', 'title': 'In-vivo', 'description': 'Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 days after surgery', 'description': 'The histopathology findings of lymph node distribution in the excised mesorectal specimen correlated with the information provided by the Sentimag probe.', 'unitOfMeasure': 'surgical mesorectal specimen', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgical mesorectal specimens', 'denomUnitsSelected': 'Surgical mesorectal specimens', 'populationDescription': 'Only patients who underwent radical surgery involving Total mesorectal excisison were included. The surgical specimens were analysed.'}, {'type': 'SECONDARY', 'title': "Number of Mesorectal Specimens Which Demonstrated Coincidence Between Histopathological and Sentimag Probe Identification of the 'Sentinel' Lymph Node", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'Surgical mesorectal specimens', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ex-vivo', 'description': 'Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}, {'id': 'OG001', 'title': 'In-vivo', 'description': 'Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 days after surgery', 'description': 'A pathologist will identify the sentinel lymph node histologically and record whether this matches the location identified by the Sentimag probe which has been previously marked with a suture', 'unitOfMeasure': 'surgical mesorectal specimen', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Surgical mesorectal specimens', 'denomUnitsSelected': 'Surgical mesorectal specimens', 'populationDescription': 'Only patients who underwent radical surgery involving Total mesorectal excisison were included. The surgical specimens were analysed.'}, {'type': 'SECONDARY', 'title': 'High Resolution MRI Composite Map of Drainage Pattern of Sienna+ Tracer in Mesorectum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'MRI scans', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ex-vivo', 'description': 'Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}, {'id': 'OG001', 'title': 'In-vivo', 'description': 'Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}], 'classes': [{'title': 'tracer uptake by tumour', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'extraneous mucosal tracer uptake', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'tracer uptake by mesorectal nodes', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Suspicious nodes on MRI after tracer injection', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'MRI scan done 2 hours after Sienna+ tracer injection', 'description': 'Evaluation of individual variability in Sienna+ distribution after endoscopic injection on high resolution MRI scans to establish a baseline for individual variation', 'unitOfMeasure': 'MRI scans', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'MRI scans', 'denomUnitsSelected': 'MRI scans', 'populationDescription': 'Only patients who had MRI scans done following tracer injection were included.'}, {'type': 'SECONDARY', 'title': 'Number of TEM Operations Where the Sentinel Lymph Node Can be Identified and Removed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'TEM operations', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ex-vivo', 'description': 'Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}, {'id': 'OG001', 'title': 'In-vivo', 'description': 'Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at time of surgery', 'description': 'Sentimag probe is used to localise the sentinel node during TEM (transanal endoscopic microsurgery) and then remove it if possible', 'unitOfMeasure': 'TEM operations', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'TEM operations', 'denomUnitsSelected': 'TEM operations', 'populationDescription': 'This measure only applies to the In-vivo group. Ex-vivo group did not undergo TEM surgery.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ex-vivo', 'description': 'Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}, {'id': 'FG001', 'title': 'In-vivo', 'description': 'Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ex-vivo', 'description': 'Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}, {'id': 'BG001', 'title': 'In-vivo', 'description': 'Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.\n\nSienna+ injection: Endoscopic injection of magnetic tracer\n\nMRI scan: MRI scan of pelvis to detect spread of magnetic tracer\n\nSurgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)\n\nSentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': '< 50 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '51-60 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '61-70 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '> 70 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pre-operative tumour T stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': 'mrT1 - tumour confined to inner bowel wall', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'mrT2 - tumour extending into muscle layer of the bowel wall', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'mrT3 - tumour has grown into the outer lining of the bowel wall', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'T component of the TNM (Tumour, Node, Metastasis) staging system, based on the pre-operative MRI scan.', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-operative N stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': 'mrN0 - no lymph nodes invaded by cancer cells', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'mrN1 - up to 3 nearby lymph nodes contain cancer cells', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'mrN2 - more than 3 lymph nodes contain cancer cells', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'N component of the TNM (Tumour, Node, Metastasis) staging system, based on the pre-operative MRI scan.', 'unitOfMeasure': 'Participants'}, {'title': 'Prior treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Nil', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Chemoradiation', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Local excision', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumour diameter', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'BG000', 'lowerLimit': '0.5', 'upperLimit': '7.0'}, {'value': '2.8', 'groupId': 'BG001', 'lowerLimit': '2.0', 'upperLimit': '3.5'}, {'value': '3.0', 'groupId': 'BG002', 'lowerLimit': '0.5', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'centimeter', 'dispersionType': 'FULL_RANGE'}, {'title': 'Tumour height above anal margin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '1.5', 'upperLimit': '15'}, {'value': '11', 'groupId': 'BG001', 'lowerLimit': '10', 'upperLimit': '12'}, {'value': '8', 'groupId': 'BG002', 'lowerLimit': '1.5', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'centimeter', 'dispersionType': 'FULL_RANGE'}, {'title': 'Tumour location', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': 'anterior', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'lateral', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'posterior', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-15', 'size': 532611, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-20T12:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Logistical difficulties in recruiting patients led to slower than expected recruitment. Recruitment was completely suspended during Covid and will not be restarted.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-15', 'studyFirstSubmitDate': '2015-05-01', 'resultsFirstSubmitDate': '2022-01-07', 'studyFirstSubmitQcDate': '2015-05-12', 'lastUpdatePostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-07', 'studyFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing of Adverse or Hypersensitivity Reaction', 'timeFrame': '5 days after injection', 'description': 'Assess frequency of any adverse of hypersensitivity reactions to tracer after endoscopic injection'}, {'measure': 'Number of Operations Where Effects of Tracer Injection Can be Detected by Surgeon During Surgery', 'timeFrame': 'at time of surgery', 'description': 'Assess frequency of Sienna+ tracer being detectable at the tumour injection site and in the lymph nodes at the time of surgery'}, {'measure': 'Number of Operations Where There Was Any Surgical Difficulty Due to Tracer Injection Based on Qualitative Assessment by Surgeon', 'timeFrame': 'at time of surgery', 'description': "Surgeon's qualitative assessment of any difficulties encountered during surgery which could be attributable to prior injection of the tracer, such as pigmentation or fibrosis making surgery more difficult than normal"}], 'secondaryOutcomes': [{'measure': 'Number of Mesorectal Specimens Which Demonstrated Correlation Between Histopathology and Sentimag Probe Findings for Lymph Node Number and Location', 'timeFrame': '5 days after surgery', 'description': 'The histopathology findings of lymph node distribution in the excised mesorectal specimen correlated with the information provided by the Sentimag probe.'}, {'measure': "Number of Mesorectal Specimens Which Demonstrated Coincidence Between Histopathological and Sentimag Probe Identification of the 'Sentinel' Lymph Node", 'timeFrame': '5 days after surgery', 'description': 'A pathologist will identify the sentinel lymph node histologically and record whether this matches the location identified by the Sentimag probe which has been previously marked with a suture'}, {'measure': 'High Resolution MRI Composite Map of Drainage Pattern of Sienna+ Tracer in Mesorectum', 'timeFrame': 'MRI scan done 2 hours after Sienna+ tracer injection', 'description': 'Evaluation of individual variability in Sienna+ distribution after endoscopic injection on high resolution MRI scans to establish a baseline for individual variation'}, {'measure': 'Number of TEM Operations Where the Sentinel Lymph Node Can be Identified and Removed', 'timeFrame': 'at time of surgery', 'description': 'Sentimag probe is used to localise the sentinel node during TEM (transanal endoscopic microsurgery) and then remove it if possible'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rectal cancer', 'Sentinel Lymph Node Biopsy'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study will assess whether the Sienna+/Sentimag system, which involves a magnetic tracer, is effective in identifying the sentinel lymph node in rectal cancer and whether it is then feasible to remove this lymph node during surgery to locally excise early rectal cancer.', 'detailedDescription': 'One issue in managing rectal cancer is identifying which patients will benefit from less radical surgery, which is much safer and better tolerated. However it does not remove lymph nodes where cancer cells may have spread. If lymph nodes containing cancer are left behind, the cancer may recur. So this surgery is only suitable in early rectal cancers not involving lymph nodes. Unfortunately, current investigations do not always accurately identify involved lymph nodes.\n\nSentinel lymph node biopsy (SLNB) is a technique to surgically remove the first lymph node where cancer cells spread. If this lymph node contains cancer, radical surgery is needed to reduce the risk of recurrence. However if it is clear, less radical surgery should be sufficient. This is standard practice for breast cancer and avoids unnecessary major surgery in many patients.\n\nThe investigators aim to assess whether SLNB is useful in rectal cancer. The investigators will determine whether the Sienna+/Sentimag system effectively identifies the sentinel lymph node, and whether the node can then be removed surgically.\n\nThe investigators will recruit patients in Oxford hospitals about to undergo surgery for rectal cancer. Patients will receive an injection of magnetic tracer during endoscopy prior to surgery. Some patients will have an extra MRI scan. During or after surgery, depending on the type of operation planned, a magnetic probe will be used to locate the sentinel lymph node in the tissue around the rectum. The removed specimen will be examined by a pathologist. Funding to undertake this study has been granted by the National Institute for Health Research (NIHR). Endomagnetics, the manufacturer, will supply the magnetic tracer and probe for use in this study.\n\nIf successful, the investigators will plan a larger clinical trial. This could have a major impact on improving outcomes for patients by allowing less radical surgery to be used where it is most appropriate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosed with operable rectal cancer\n* case discussed at Oxford Colorectal Cancer multi-disciplinary team (MDT) meeting\n* willing and able to give informed consent\n* willing and able to comply with all trial requirements, in the investigator's opinion\n\nExclusion Criteria:\n\n* females who are pregnant or lactating\n* known intolerance or hypersensitivity to iron, dextran compounds, magnetic tracers or superparamagnetic iron oxide particles (SPIO)\n* cancer involvement of anal sphincter complex\n* adults who are not able to give consent or are deemed vulnerable"}, 'identificationModule': {'nctId': 'NCT02445456', 'acronym': 'SentiRect', 'briefTitle': 'Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer', 'orgStudyIdInfo': {'id': 'R37025/CN339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ex-vivo', 'description': 'Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo.', 'interventionNames': ['Drug: Sienna+ injection', 'Procedure: Surgery to excise rectal cancer', 'Device: Sentimag probe']}, {'type': 'EXPERIMENTAL', 'label': 'In-vivo', 'description': 'Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology.', 'interventionNames': ['Drug: Sienna+ injection', 'Other: MRI scan', 'Procedure: Surgery to excise rectal cancer', 'Device: Sentimag probe']}], 'interventions': [{'name': 'Sienna+ injection', 'type': 'DRUG', 'description': 'Endoscopic injection of magnetic tracer', 'armGroupLabels': ['Ex-vivo', 'In-vivo']}, {'name': 'MRI scan', 'type': 'OTHER', 'description': 'MRI scan of pelvis to detect spread of magnetic tracer', 'armGroupLabels': ['In-vivo']}, {'name': 'Surgery to excise rectal cancer', 'type': 'PROCEDURE', 'description': 'Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)', 'armGroupLabels': ['Ex-vivo', 'In-vivo']}, {'name': 'Sentimag probe', 'type': 'DEVICE', 'description': 'Probe to detect the previously injected magnetic tracer (Sienna+)', 'armGroupLabels': ['Ex-vivo', 'In-vivo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Chris Cunningham, MD FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Leeds', 'class': 'OTHER'}, {'name': 'Endomagnetics Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr', 'investigatorFullName': 'Chris Cunningham', 'investigatorAffiliation': 'Oxford University Hospitals NHS Trust'}}}}