Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT01684735
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2012-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-27', 'studyFirstSubmitDate': '2012-05-14', 'studyFirstSubmitQcDate': '2012-09-12', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to chemotherapy', 'timeFrame': '1 year', 'description': 'outcome is the results of pathology after chemotherapy and surgery. Data will be collected for a period of 1 year.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diffusion-weighted magnetic resonance imaging'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Evaluation of the response to chemotherapy in breast cancer patients by the use of Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy, after one and 3 cycles of therapy and at the end of the therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'women diagnosed with breast cancer and treated with neo-adjuvant chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* core biopsy with diagnosis of breast cancer\n* start of neo-adjuvant chemotherapy\n\nExclusion Criteria:\n\n* magnetic resonance imaging incompatibility'}, 'identificationModule': {'nctId': 'NCT01684735', 'briefTitle': 'Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation', 'orgStudyIdInfo': {'id': 'B322201213618'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women with BRCA and chemotherapy', 'description': 'women recently diagnosed with breast cancer and start with neo-adjuvant chemotherapy (6 cycles) before surgery/therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '300', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Chantal Van Ongeval, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}