Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-01-05 @ 5:43 PM
Study NCT ID:
NCT00604266
Status:
WITHDRAWN
Last Update Posted:
2017-05-04
First Post:
2008-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coregistration of 18F-FDG-PET and MRI in the Staging of Potentially Resectable Hilar Cholangiocarcinoma: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2008-01-17', 'studyFirstSubmitQcDate': '2008-01-29', 'lastUpdatePostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Potentially resectable hilar cholangiocarcinoma as per initial imaging studies.', 'Able to undergo PET/CT and MRI with Gadolinium'], 'conditions': ['Cholangiocarcinoma']}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility and performance of coregistered 18F-FDG-PET/MRI in the staging of potentially respectable hilar cholangiocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fifteen patients with potentially resectable hilar cholangiocarcinomas, as determined by conventional imaging modalities, will be recruited. In order to minimize false positive uptake of 18F-FDG due to inflammatory changes, patients will be recruited either before biliary stenting, or after biliary stenting if there is no clinical evidence of active cholangitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hilar cholangiocarcinoma assessed by conventional imaging modalities (triphasic CT scan of the liver) and thought to be potentially resectable.\n\nExclusion Criteria:\n\n* Biliary drain inserted.\n* Contraindication for MRI.\n* Pregnant or breast-feeding.\n* Uncontrolled diabetes (over 9.7 mmol/L).'}, 'identificationModule': {'nctId': 'NCT00604266', 'acronym': 'PET/MRCP', 'briefTitle': 'Coregistration of 18F-FDG-PET and MRI in the Staging of Potentially Resectable Hilar Cholangiocarcinoma: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Coregistration of 18F-FDG-PET and MRI in the Staging of Potentially Resectable Hilar Cholangiocarcinoma: a Pilot Study.', 'orgStudyIdInfo': {'id': '07-0216'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '10-15 patients with potentially resectable hiilar cholangiocarcinoma'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1Z5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'UHN - Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Ur Metser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U of Toronto, UHN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Health Network, Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division Head, Molecular Imaging, Joint Department of Medical Imaging', 'investigatorFullName': 'Ur Metser', 'investigatorAffiliation': 'University of Toronto'}}}}