Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-31 @ 11:25 AM
Study NCT ID:
NCT00804128
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2008-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast-Enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], '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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C090600', 'term': 'gadobutrol'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-22', 'size': 227668, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-17T16:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2008-12-05', 'studyFirstSubmitQcDate': '2008-12-05', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of ductal carcinoma in situ (DCIS)-optimized MRI quality', 'timeFrame': '1 month', 'description': 'Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image quality for each MRI.'}, {'measure': 'Comparison of two DCIS-optimized MRIs for variability in enhancement levels for DCIS', 'timeFrame': '1 month', 'description': 'Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image variability for each MRI.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ductal breast carcinoma in situ'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '\\*REFERRALS TO THIS TRIAL MUST BE THROUGH BREAST CARE CLINICIANS ONLY\\*\n\nRATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose ductal carcinoma in situ.\n\nPURPOSE: This study is to develop and refine magnetic resonance (MR) imaging methods for pre-operative staging of ductal carcinoma in situ, a pre-invasive form of breast cancer, and atypical ductal hyperplasia, a risk factor for developing cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the DCIS optimized MRI to the standard clinical MRI. Using a scale of 1-5 from poor to excellent, images will be assessed for conspicuity of DCIS and atypical ductal hyperplasia (ADH) lesions, agreement of disease extent with biopsy, and overall image quality (artifact level, uniformity of fat suppression, contrast to noise ratio and signal to noise ratio).\n* Subjects with ADH, a benign condition that can also show enhancement on MRI, will be enrolled to explore the utility of the DCIS optimized MRI for distinguishing DCIS and ADH.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants receiving care for breast cancer who also have a biopsy proven DCIS or ADH.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n * Patients at the University of California, San Francisco Breast Care Center meeting the following criteria:\n\n * Biopsy proven ductal carcinoma in situ (DCIS) of the breast.\n * Has undergone mammography within the past 60 days.\n * ADH patients: over 18, no prior history of breast disease.\n\nPATIENT CHARACTERISTICS:\n\n* Referrals to this trial are through breast care clinicians only\n* Not pregnant or nursing (or stopped nursing within the past 3 months)\n* Negative pregnancy test\n* No contraindication to MRI (e.g., implanted pacemaker, implanted ferromagnetic device, ferromagnetic aneurysm clip, severe claustrophobia, ocular metal fragments, or shrapnel injury)\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 2 years since prior surgery to the ipsilateral breast (patient)\n* No prior radiotherapy to the ipsilateral breast (patient)\n* No prior cytotoxic regimens (patient)'}, 'identificationModule': {'nctId': 'NCT00804128', 'briefTitle': 'Contrast-Enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Contrast-enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)', 'orgStudyIdInfo': {'id': 'CDR0000616972'}, 'secondaryIdInfos': [{'id': '08755', 'type': 'OTHER', 'domain': 'University of California, San Francisco'}, {'id': 'NCI-2019-07528', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program (CTRP)'}, {'id': 'R01CA116182', 'link': 'https://reporter.nih.gov/quickSearch/R01CA116182', 'type': 'NIH'}, {'id': 'U01CA225427', 'link': 'https://reporter.nih.gov/quickSearch/U01CA225427', 'type': 'NIH'}, {'id': 'R01CA249016', 'link': 'https://reporter.nih.gov/quickSearch/R01CA249016', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer patients', 'description': 'Adult, breast cancer patients with confirmed Ductal Carcinoma in Situ (DCIS) or atypical ductal hyperplasia (ADH)', 'interventionNames': ['Procedure: Magnetic Resonance Imaging (MRI)', 'Drug: Gadavist']}], 'interventions': [{'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'PROCEDURE', 'otherNames': ['MRI'], 'description': 'Undergo MRI', 'armGroupLabels': ['Breast Cancer patients']}, {'name': 'Gadavist', 'type': 'DRUG', 'otherNames': ['Gadobutrol'], 'description': 'Gadavist injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging', 'armGroupLabels': ['Breast Cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Nola M. Hylton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Bonnie Joe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}