Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT00874458
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2009-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ
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': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2009-04-01', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of tumor extension by MRI with surgical histology', 'timeFrame': 'up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ductal breast carcinoma in situ'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread.\n\nPURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Assess the contribution of MRI in accurately determining tumor size in women with ductal breast carcinoma in situ (DCIS).\n\nSecondary\n\n* Evaluate the sensitivity of MRI in detecting DCIS.\n* Evaluate the contribution of mammography in accurately determining tumor size.\n* Compare the contribution of MRI vs mammography in assessing tumor extension.\n* Compare the contribution of MRI vs mammography in assessing dense breasts.\n* Evaluate the morphology of DCIS by MRI.\n* Evaluate the curve of dynamic MRI in assessing DCIS.\n* Evaluate the impact of nuclear grade of DCIS by MRI.\n* Evaluate the rate of revision surgery.\n\nOUTLINE: Patients undergo clinical examination, mammography, ultrasound imaging, unilateral breast MRI, and tissue sampling.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of ductal breast carcinoma in situ\n\n * Any grade disease allowed\n* Unifocal disease by mammography\n* No history of breast cancer\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n* WHO performance status 0-2\n* Glomerular filtration rate ≥ 30 mL/min\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No allergy or contraindication to contrast MRI\n* No pacemaker or vascular clip\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior or concurrent liver transplantation'}, 'identificationModule': {'nctId': 'NCT00874458', 'briefTitle': 'MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ', 'organization': {'class': 'OTHER', 'fullName': 'Centre Antoine Lacassagne'}, 'officialTitle': 'Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI', 'orgStudyIdInfo': {'id': '2006/25'}, 'secondaryIdInfos': [{'id': 'CALACASS-CCIS'}, {'id': 'CALACASS-2006/25'}, {'id': '2006-A00251-50', 'type': 'OTHER', 'domain': 'AFSSAPS ID RCB'}, {'id': 'INCA-RECF0620'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI', 'interventionNames': ['Procedure: magnetic resonance imaging', 'Procedure: radiomammography', 'Procedure: ultrasound imaging']}], 'interventions': [{'name': 'magnetic resonance imaging', 'type': 'PROCEDURE', 'armGroupLabels': ['MRI']}, {'name': 'radiomammography', 'type': 'PROCEDURE', 'armGroupLabels': ['MRI']}, {'name': 'ultrasound imaging', 'type': 'PROCEDURE', 'armGroupLabels': ['MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Claire Chapellier', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Antoine Lacassagne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Antoine Lacassagne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}