Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT00656604
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2008-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015412', 'term': 'Mastectomy, Segmental'}, {'id': 'D008408', 'term': 'Mastectomy'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-04', 'studyFirstSubmitDate': '2008-04-10', 'studyFirstSubmitQcDate': '2008-04-10', 'lastUpdatePostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of data obtained by DCE-MRI and magnetic resonance spectroscopy (MRS) with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology in women with breast cancer', 'timeFrame': 'At time of breast surgery', 'description': "Imaging and spectroscopic studies are performed before surgery. After surgery, this data will be compared and contrast with data obtained from conventional mammograms and the patient's tissue."}], 'secondaryOutcomes': [{'measure': 'Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer', 'timeFrame': 'After the last scan', 'description': "Investigators will evaluate the effectiveness of spectroscopic data used to plan for the patient's post-imaging surgery and/or post-surgical radiotherapy."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent breast cancer', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI), magnetic resonance spectroscopy (MRS), and tissue proteomics, may help doctors find and diagnose breast cancer and plan the best treatment.\n\nPURPOSE: This clinical trial is studying MRI and MRS with or without tissue proteomics analysis to see how well they work in evaluating healthy women and women who are undergoing surgery for breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To correlate data obtained by DCE-MRI and MRS in healthy women and in women who are undergoing surgery for breast cancer with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology.\n* To evaluate the impact of MRSI data on treatment planning for radiotherapy and/or surgery.\n\nOUTLINE: Healthy participants undergo dynamic contrast-enhanced (DCE)-MRI and magnetic resonance spectroscopic (MRS) for longitudinal studies of breast imaging and spectroscopy.\n\nPatients with breast cancers undergo DCE-MRI and MRS prior to initiation of treatment (i.e., surgery, chemotherapy, or radiotherapy). After treatment has begun, patients then undergo repeat imaging (not more than 1 per month) for follow-up assessments and longitudinal studies.\n\nBreast tissue samples are collected from patients undergoing surgery. Samples are evaluated by histopathological and proteomic analysis for correlation with DCE-MRI and MRS findings.\n\nThe study interventions are discontinued after definitive surgery is performed.\n\nPROJECTED ACCRUAL: A total of 10 healthy participants and 40 patients with breast cancer will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n * Women with breast tumors planning to undergo surgical resection\n * Healthy volunteers, including any constitutionally healthy female with no history of breast cancer\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Menopausal status not specified\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Not acutely ill\n* No non-magnetic resonance-compatible ferromagnetic materials present in the body\n\nPRIOR CONCURRENT THERAPY:\n\n* Prior chemotherapy and/or radiotherapy allowed'}, 'identificationModule': {'nctId': 'NCT00656604', 'briefTitle': 'Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics', 'orgStudyIdInfo': {'id': 'VICC BRE 0358'}, 'secondaryIdInfos': [{'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VU-VICC-BRE-0358'}, {'id': 'VU-VICC-IRB-030472'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Women with breast cancer', 'description': 'Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.', 'interventionNames': ['Genetic: proteomic profiling', 'Procedure: lumpectomy or mastectomy', 'Procedure: dynamic contrast-enhanced magnetic resonance imaging', 'Procedure: histopathologic examination', 'Procedure: magnetic resonance spectroscopy']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy volunteers', 'description': 'Women without breast cancer undergo DCE-MRI and MRS.'}], 'interventions': [{'name': 'proteomic profiling', 'type': 'GENETIC', 'otherNames': ['proteomic analysis'], 'description': 'at the time of each procedure.', 'armGroupLabels': ['Women with breast cancer']}, {'name': 'lumpectomy or mastectomy', 'type': 'PROCEDURE', 'otherNames': ['None noted'], 'description': 'removal of breast tumor or removal of the entire breast in which the tumor is located', 'armGroupLabels': ['Women with breast cancer']}, {'name': 'dynamic contrast-enhanced magnetic resonance imaging', 'type': 'PROCEDURE', 'otherNames': ['DCE-MRI'], 'description': 'Prior to initiation of treatment', 'armGroupLabels': ['Women with breast cancer']}, {'name': 'histopathologic examination', 'type': 'PROCEDURE', 'otherNames': ['Not noted'], 'description': 'After the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer', 'armGroupLabels': ['Women with breast cancer']}, {'name': 'magnetic resonance spectroscopy', 'type': 'PROCEDURE', 'otherNames': ['MRS'], 'description': 'Prior to initiation of treatment', 'armGroupLabels': ['Women with breast cancer']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'A. Bapsi Chakravarthy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'A Bapsi Chakravarthy, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}