Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-07 @ 7:19 AM
Study NCT ID:
NCT00474604
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2007-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants
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': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'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': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2007-05-16', 'studyFirstSubmitQcDate': '2007-05-16', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of advanced, quantitative, multi-parametric magnetic resonance imaging (MRI) methods for characterizing breast tumors to develop potential surrogate imaging markers for diagnosis and prediction of treatment response', 'timeFrame': 'on-study date and at 6 months, up to 4 years', 'description': 'Quantitative, multi-parametric MRI imaging methods include Dynamic Contrast MRI, Diffusion Weighted MRI, and Magnetic Resonance Spectroscopy. Patients will include healthy female volunteers and women diagnosed with breast cancer. Time frames begin at study entry (healthy volunteers) , pre-surgical and pre- and post-chemotherapy (breast cancer patients)'}], 'secondaryOutcomes': [{'measure': 'Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings', 'timeFrame': 'at 6 months', 'description': "Biochemical data from advanced MRIs are compared and contrasted with findings from patients' clinical, chemotherapeutic, and radiologic treatments for breast cancer."}, {'measure': 'Establishment of an imaging data bank', 'timeFrame': 'at 6 months', 'description': 'Results of advanced MRI imaging methods for subjects assessed after completion of all MRI procedures'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '17222711', 'type': 'RESULT', 'citation': 'Yankeelov TE, Lepage M, Chakravarthy A, Broome EE, Niermann KJ, Kelley MC, Meszoely I, Mayer IA, Herman CR, McManus K, Price RR, Gore JC. Integration of quantitative DCE-MRI and ADC mapping to monitor treatment response in human breast cancer: initial results. Magn Reson Imaging. 2007 Jan;25(1):1-13. doi: 10.1016/j.mri.2006.09.006. Epub 2006 Nov 21.'}, {'pmid': '23157877', 'type': 'DERIVED', 'citation': 'Li X, Abramson RG, Arlinghaus LR, Chakravarthy AB, Abramson V, Mayer I, Farley J, Delbeke D, Yankeelov TE. An algorithm for longitudinal registration of PET/CT images acquired during neoadjuvant chemotherapy in breast cancer: preliminary results. EJNMMI Res. 2012 Nov 16;2(1):62. doi: 10.1186/2191-219X-2-62.'}], 'seeAlsoLinks': [{'url': 'http://www.vicc.org/ct/', 'label': 'Vanderbilt-Ingram Cancer Center, Find a Clinical Trial'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Diagnostic procedures, such as MRI, may help diagnose breast cancer. It may also help doctors predict a patient's response to treatment.\n\nPURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast cancer and in healthy participants.", 'detailedDescription': 'OBJECTIVES:\n\n* Develop and combine advanced, quantitative, multiparametric magnetic resonance imaging methods (i.e., dynamic contrast-enhanced MRI \\[DCE-MRI\\], diffusion-weighted MRI \\[DW-MRI\\], and magnetic resonance spectroscopy \\[MRS\\]) to characterize breast tumors in women with known or suspected breast cancer.\n* Identify surrogate biomarkers that can guide diagnosis and treatment of breast cancer using these methods.\n* Correlate biochemical information obtained from magnetic resonance analysis with clinical, radiologic, and pathologic findings in these patients.\n* Establish an imaging data bank that includes information on DCE-MRI, DW-MRI, and MRS findings in these patients and in healthy participants.\n\nOUTLINE: Quantitative, multi-parametric magnetic imaging methods will be employed for breast imaging for the following subjects:\n\n* Group A: Healthy volunteers who undergo up to 3 breast MRIs over 6 weeks.\n* Group B: Patients diagnosed with breast cancer who will: 1) undergo preoperative breast MRI followed by definitive surgery or 2) undergo MRI prior to initiating neoadjuvant chemotherapy, at 1-2 weeks after initiation of chemotherapy, and prior to definitive surgery.\n\nClinical information, including radiologic and pathologic data, on all patients is collected for inclusion in the imaging data bank.\n\nAfter completion of the study, patients and healthy participants are followed periodically.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nWomen who satisfy the following conditions are the only subjects who will be eligible for this study:\n\n* Normal volunteers\n* Subjects with known or suspected breast disease\n* Subjects must have signed an approved consent form.\n* Subjects must be ≥ 18 years old.\n* The protocol nurse will check with the patient that there is no h/o kidney disease\n* Normal creatinine and estimated GFR\\* within 30 days under the following circumstances\n\n * Had abnormal creatinine in the last 60 days\n * Are over 60 years of age\n * Has received chemotherapy within the past 30 days\n * Has diabetes, HIV, renal disease or hx of renal cancer\n* \\* GFR will be calculated using: http://www.kidney.org/professionals/kdoqi/gfr\\_calculator.cfm\n* Patients with an eGFR\\>90ml/min reported within 30 days, and who have not had intervening chemotherapy or other treatment or condition that might deteriorate renal function, may receive any gadolinium agent.\n\nExclusion Criteria:\n\n* Children will be excluded from this study.\n* Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "MRI Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for each pre-menopausal subject.)\n* Subjects found to have any constitutionally present non-MR compatible ferromagnetic materials will be excluded from this study.\n* Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study\n* Subjects for whom an MRI is technically not feasible (e.g. breast volume, obesity)\n* Subjects who have vascular access ports or other implanted devices rated as anything other than "Safe" or "Conditional 6"'}, 'identificationModule': {'nctId': 'NCT00474604', 'briefTitle': 'Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'MRI Evaluation of Breast Tumor Growth and Treatment Response', 'orgStudyIdInfo': {'id': 'VICC BRE 0588'}, 'secondaryIdInfos': [{'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VU-VICC-BRE-0588'}, {'id': 'VU-VICC-IRB-051230'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Participants without breast cancer', 'interventionNames': ['Procedure: diffusion-weighted magnetic resonance imaging', 'Procedure: dynamic contrast-enhanced magnetic resonance imaging', 'Procedure: magnetic resonance spectroscopic imaging']}, {'type': 'EXPERIMENTAL', 'label': 'Participants with breast cancer', 'interventionNames': ['Procedure: diffusion-weighted magnetic resonance imaging', 'Procedure: dynamic contrast-enhanced magnetic resonance imaging', 'Procedure: magnetic resonance spectroscopic imaging']}], 'interventions': [{'name': 'diffusion-weighted magnetic resonance imaging', 'type': 'PROCEDURE', 'description': 'A scan will be performed.', 'armGroupLabels': ['Participants with breast cancer', 'Participants without breast cancer']}, {'name': 'dynamic contrast-enhanced magnetic resonance imaging', 'type': 'PROCEDURE', 'description': 'A scan will be performed.', 'armGroupLabels': ['Participants with breast cancer', 'Participants without breast cancer']}, {'name': 'magnetic resonance spectroscopic imaging', 'type': 'PROCEDURE', 'description': 'A scan will be performed.', 'armGroupLabels': ['Participants with breast cancer', 'Participants without breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'A. Bapsi Chakravarthy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', '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': 'Professor; Radiation Oncology', 'investigatorFullName': 'A Bapsi Chakravarthy, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}