Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-29 @ 9:43 AM
Study NCT ID:
NCT02688257
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2016-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Treatment Response in Breast Cancer With Functional Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2016-02-08', 'studyFirstSubmitQcDate': '2016-02-17', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early and late changes of oxygenation and residual cellularity of patients treated with neoadjuvant chemotherapy, measured using the blood oxygen level dependent (BOLD) technique.', 'timeFrame': '6 years', 'description': 'The primary aim of the study is to determine whether specific MRI sequences including dynamic contrast enhanced (DCE) MRI, T2\\*, diffusion weighted (DW) MRI, as well as microbubble and optoacoustic ultrasound imaging provide early measures of treatment response in breast tumours treated with neoadjuvant chemotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Magnetic Resonance Imaging', 'Ultrasound', 'Breast Cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Patients with large primary operable breast cancers are offered chemotherapy prior to surgery to shrink the tumour and enable breast conserving surgery. Conventional assessment of response to chemotherapy relies on a change in tumour size which does not always correlate with the change in amount of viable tumour. Newer techniques such as functional MRI, microbubble and optoacoustic ultrasound offer the potential to detect responses to chemotherapy by evaluating functional changes in tumour vascularity and oxygenation. Neither modality utilises ionising radiation.\n\nAlthough MRI is widely used for detecting breast cancer, its ability in assessing functional responses to chemotherapy prior to surgery has not been fully exploited. Dynamic contrast enhanced (DCE) MRI has a sensitivity around 90% and provides quantitative measurements of blood volume and flow. Other functional techniques detect variation in tissue oxygenation: this is called the blood oxygen level-dependent (BOLD) mechanism. The BOLD technique uses a special magnetic resonance (MR) sequence called T2\\* to measure the weakly magnetic effect of deoxygenated haemoglobin. The investigators wish to develop and validate T2\\* measurements which relate to oxygenation of a tumour. The investigators also want to validate other MR sequences including diffusion weighted (DW) MRI, which quantifies microcirculation of blood in the capillary network and the diffusion of water within tissues.\n\nMicrobubble ultrasound is an established technique that utilises an intravenous contrast agent comprising tiny microbubbles of gas that can increase the reflectivity of blood and enhance spectral and colour Doppler signals obtained from routine ultrasound imaging. Optoacoustic imaging is new technique where the output signal depends on the oxygenation of the tissues under study. It utilises a light signal input and measures ultrasound signal output.\n\nThe investigators want to correlate our imaging findings with histopathology after surgical resection of the tumour.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with breast cancer who are due for neoadjuvant chemotherapy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with breast cancer due for neoadjuvant chemotherapy\n\nExclusion Criteria:\n\n* Ferromagnetic implants within body in accordance with standard clinical practice\n* claustrophobia\n* age \\<18 or \\>90'}, 'identificationModule': {'nctId': 'NCT02688257', 'briefTitle': 'Assessing Treatment Response in Breast Cancer With Functional Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Cancer Research, United Kingdom'}, 'officialTitle': 'Assessing Treatment Response of Breast Cancer Using Multimodal Functional Imaging', 'orgStudyIdInfo': {'id': '10/H0806/50 CCR3372'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI', 'type': 'OTHER', 'description': 'Functional magnetic resonance imaging'}, {'name': 'Ultrasound', 'type': 'OTHER', 'description': 'Optoacoustic imaging'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'The Institute of Cancer Research and Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Nandita DeSouza', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Research UK', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Nandita DeSouza', 'investigatorFullName': 'NdeSouza', 'investigatorAffiliation': 'Institute of Cancer Research, United Kingdom'}}}}