Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-24 @ 5:25 PM
Study NCT ID:
NCT02910804
Status:
UNKNOWN
Last Update Posted:
2018-01-18
First Post:
2016-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-16', 'studyFirstSubmitDate': '2016-09-16', 'studyFirstSubmitQcDate': '2016-09-21', 'lastUpdatePostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM', 'timeFrame': '1 year', 'description': 'The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in GBM will be measured.'}, {'measure': 'Margin assessment of positive tumors in NIRF fluorescent-guided surgery', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GBM', 'GRPR', 'IRDye800', 'NIRF', 'surgery'], 'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': 'This is an open-label positron emission tomography/near infrared (PET/NIRF) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68Ga-BBN-IRDye800CW in glioblastoma (GBM) patients. A single dose of 40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW will be injected intravenously before the operation and intraoperative respectively. Visual and semiquantitative method will be used to assess the PET images and real-time margins localization for surgical navigation.', 'detailedDescription': 'Non-invasive preoperative PET imaging evaluation and real-time fluorescence-guided surgery would be of great help in GBM patients. BBN, with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (GRPR), a member of the G protein-coupled receptor family of bombesin receptors that over-expressed in various types of cancer cells including glioblastoma multiforme. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIFR study was designed to investigate the safety and imaging guiding performance of 68Ga-BBN-IRDye800CW in patients with GBM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to provide a written informed consent\n* MRI imaging and/or pathological evidence of Newly Diagnosed or recurrence GBM\n\nExclusion Criteria:\n\n* Consisted of conditions of mental illness\n* Severe liver or kidney disease with serum creatinine \\> 3.0 mg/dl (270 μΜ)\n* Any hepatic enzyme level 5 times or more than normal upper limit\n* Severe allergy or hypersensitivity to IV radiographic contrast\n* Claustrophobia to accept the PET/CT scanning\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT02910804', 'briefTitle': 'IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma', 'orgStudyIdInfo': {'id': 'BTHospital-N-005'}, 'secondaryIdInfos': [{'id': 'ZIAEB000073', 'link': 'https://reporter.nih.gov/quickSearch/ZIAEB000073', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-BBN-IRDye800CW PET/NIRF', 'description': 'The patients were injected with 40μg/111-148 Mega-Becquerel (MBq) 68Ga-BBN-IRDye800CW in one dose intravenously and then underwent PET scan 30 min later before the operation and intraoperative 1.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery.', 'interventionNames': ['Drug: 68Ga-BBN-IRDye800CW', 'Device: PET/NIRF', 'Procedure: PET/NIR fluorescent imaging-guided surgery']}], 'interventions': [{'name': '68Ga-BBN-IRDye800CW', 'type': 'DRUG', 'otherNames': ['BBN-IRDye800CW'], 'armGroupLabels': ['68Ga-BBN-IRDye800CW PET/NIRF']}, {'name': 'PET/NIRF', 'type': 'DEVICE', 'otherNames': ['Positron emission tomography/Near-infrared fluorescent'], 'armGroupLabels': ['68Ga-BBN-IRDye800CW PET/NIRF']}, {'name': 'PET/NIR fluorescent imaging-guided surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['68Ga-BBN-IRDye800CW PET/NIRF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Deling Li, MD.', 'role': 'CONTACT', 'email': 'ttyyneuroli@126.com', 'phone': '+86 10 69154196'}], 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Deling Li, MD', 'role': 'CONTACT', 'email': 'ttyyneuroli@126.com'}, {'name': 'Jingjing Zhang, MD.', 'role': 'CONTACT', 'email': 'zhangjingjingtag@163.com'}], 'overallOfficials': [{'name': 'Nan Ji, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Tiantan Hospital, Capital Medical University Beijing 100050, China'}, {'name': 'Zhaohui Zhu, MD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': 'National Institute for Biomedical Imaging and Bioengineering (NIBIB)', 'class': 'NIH'}, {'name': 'Chinese Academy of Sciences', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Deling Li', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}