Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-03 @ 10:00 PM
Study NCT ID:
NCT02462460
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2015-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Pancreatic and Ovarian Screening MR Imaging With Motion Corrected T1, T2, and Advanced Diffusion Weighted Imaging for Patients With BRCA Mutation Who Undergo Screening Breast MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2015-06-02', 'studyFirstSubmitQcDate': '2015-06-02', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'define optimized acquisition', 'timeFrame': '1 year', 'description': 'The images will be evaluated qualitatively for image quality from 1 to 5 with 5 = not adequate and 1 = adequate image quality by two radiologists in consensus. If both radiologists give a score of 1, the sequence will be considered to be adequate in image quality. Quantitative measurements of SNR will be performed on the pancreatic head, body and tail, and ovarian tissue by region of interest (ROI) analysis. Final acquisition times and spatial resolution for each sequence will be recorded.'}]}, 'conditionsModule': {'keywords': ['Breast MRI', 'T1 weighted and diffusion weighted MR', 'screening pancreatic', 'screening ovarian', '15-120'], 'conditions': ['Screening Breast MRI in Patients Who Are BRCA Mutation Carriers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to create a rapid scan of the pancreas and ovaries that could be used in the future to screen patients at risk for pancreatic or ovarian cancers. Currently, Magnetic Resonance Imaging (MRI) examinations of the pancreas and ovaries can last 30-45 minutes each. The investigators hope to create a rapid pancreatic and ovarian MRI evaluation that can be used as a screening tool that is completed in approximately 15 minutes. They will compare different tools available on modern MRI scanners to see which one reliably offers high quality images of the pancreas and ovaries.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MSKCC clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'A minimum of 5 and maximum of 60 evaluable patients will be imaged on this study. Description of the subject inclusion and exclusion criteria are listed below.\n\nInclusion Criteria:\n\n* BRCA 1 or 2 mutation\n* Age ≥ 30\n* Patients scheduled to undergo screening breast MRI with contrast\n\nExclusion Criteria:\n\n* Patients with known breast cancer\n* Patients unable to complete their scheduled breast MRI\n* Patients with prior pancreatic surgery or cancers\n* Patients with prior ovarian cancer or surgery involving removal of one or both ovaries\n* Patients with prior abdominal or pelvic surgery'}, 'identificationModule': {'nctId': 'NCT02462460', 'briefTitle': 'Rapid Pancreatic and Ovarian Screening MR Imaging With Motion Corrected T1, T2, and Advanced Diffusion Weighted Imaging for Patients With BRCA Mutation Who Undergo Screening Breast MRI', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Pilot Study Pancreatic and Ovarian Screening MR Imaging of Rapid With Motion Corrected T1, T2, and Advanced Diffusion Weighted Imaging for Patients With BRCA Mutation Who Undergo Screening Breast MRI', 'orgStudyIdInfo': {'id': '15-120'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with BRCA mutation', 'description': 'The purpose of this study is to optimize rapid pancreatic and ovarian MR screening protocols using T1, T2 and DW imaging sequences in BRCA mutation carriers. Each screening MR protocol is considered optimized if we reach 5 consecutive patients with technically adequate image quality. We will enroll up to 60 patients to perform the MR screening protocol, if the initial MR sequence parameters do not yield technically adequate MR images in a single patient, we will stop and modify our imaging protocol. We will continue to modify the technique until we reach 5 consecutive patients with technically adequate MR images for both on all imaging sequences. Thus, it is possible we will optimize different imaging sequences at different time points in our study. We plan to enroll at least 5 patients, and up to 60 patients with BRCA mutation who undergo breast MRI for this study. Participants will receive a copy of the questionnaire on the day of their Breast MRI.', 'interventionNames': ['Device: MRI', 'Behavioral: Optional Screening Questionnaire']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'armGroupLabels': ['Patients with BRCA mutation']}, {'name': 'Optional Screening Questionnaire', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Patients with BRCA mutation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Peter Sawan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}