Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT02244593
Status:
COMPLETED
Last Update Posted:
2020-09-28
First Post:
2014-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FAST MRI Study in Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-11-07', 'releaseDate': '2023-01-13'}], 'estimatedResultsFirstSubmitDate': '2023-01-13'}}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2014-06-06', 'studyFirstSubmitQcDate': '2014-09-16', 'lastUpdatePostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of tumors missed by mammography', 'timeFrame': '12 months'}], 'primaryOutcomes': [{'measure': 'The percentage of patients with reduced anxiety as a result of having a FAST MRI', 'timeFrame': 'up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Numbers of recurrent tumors in each arm', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer survivors', 'FAST MRI', 'mammography screening'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '35840916', 'type': 'DERIVED', 'citation': 'Fonseca MM, Alhassan T, Nisha Y, Koszycki D, Schwarz BA, Segal R, Arnaout A, Ramsay T, Lau J, Seely JM. Randomized trial of surveillance with abbreviated MRI in women with a personal history of breast cancer- impact on patient anxiety and cancer detection. BMC Cancer. 2022 Jul 15;22(1):774. doi: 10.1186/s12885-022-09792-x.'}]}, 'descriptionModule': {'briefSummary': "Breast Magnetic Resonance Imaging (MRI) has been shown to be the most accurate test for detecting breast cancer however, MRI is not always reliable because it can indicate the presence of cancer when in reality, there is none; this is called a 'false positive' result. A history of breast carcinoma alone does not qualify a patient for ongoing monitoring with breast MRI. This study is being done to assess a new technique called FAST breast MRI. A FAST breast MRI is different than a traditional breast MRI because it has much fewer sequences and takes approximately 3 minutes for the scan. MRI sequences are combinations of magnetic pulses that collect information about the tissues. There is no radiation associated with an MRI.\n\nThe purpose of this study is to determine the impact on patient health when a FAST breast MRI is used as a screening technique in women with a personal history of cancer. It has been shown that FAST breast MRI is similar to routine breast MRI in the detection of breast cancer, but it has not been proven that FAST breast MRI will help women who have a personal history for breast cancer. Currently, routine breast MRI is not part of the standard of care in screening for breast cancer in women who have a prior personal history of breast cancer. By evaluating FAST MRI the investigators are able to study the effects of this short MRI on cancer detection in women with a personal history of breast cancer, and on the impact on overall health. The investigators estimate that 300 participants will be enrolled in the study from The Ottawa Hospital Cancer Centre at The Ottawa Hospital, General Campus and the Women's Breast Health Centre at The Ottawa Hospital, Civic Campus. All of the participants have had a history of breast carcinoma.", 'detailedDescription': 'Given the demand for breast MRI screening by breast cancer survivors and oncologists, we plan to perform a randomized controlled trial in a select patient population of breast cancer survivors who would not normally be eligible for breast MRI screening. This study will determine whether using FAST MRI in addition to mammography will reduce anxiety in patients compared to the current standard of care: mammography alone. If it turns out to reduce anxiety, the next step would be to conduct a large-scale multi-centre randomized control trial (RCT) to evaluate whether FAST MRI is more sensitive and whether the increased sensitivity leads to improved clinical outcomes.\n\nThe purpose of our study is to determine the impact on patient anxiety of FAST Breast MRI as a surveillance technique in women with a personal history of breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* English or French speaking female patients over the age of 18 years, with a personal history of a diagnosis of breast carcinoma (including ductal carcinoma in situ (DCIS) and invasive ductal or lobular carcinoma) within the past 10 years.\n* Patients must have completed treatment for their breast cancer.\n* Moderate risk for recurrence of breast cancer, defined as lifetime risk of breast cancer greater than 12% (average risk) and less than 25% (high risk) as defined using the Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm (BOADICEA) model (see Appendix A)\n* Patients who have undergone unilateral mastectomy or breast conservation surgery.\n* Normal renal function: estimated glomerular filtration rate (eGFR) \\> 30 ml/min/m2\n\nExclusion Criteria:\n\n* Patients unable to undergo an MRI, due to either physical or mental issues (i.e.: anxiety or severe claustrophobia). Also, patient with a known allergy to gadolinium, or severe renal failure will be excluded.\n* Pregnant or breastfeeding patients.\n* Patients who have had a breast MRI within the last 6 months.\n* Patients already receiving high-risk breast MRI screening, such as the Ontario Breast Screening Program (OBSP) high-risk program and the Women's Breast Health Center (WBHC) high-risk program.\n* Patients who have undergone bilateral mastectomies.\n* Poor renal function: estimated glomerular filtration rate (eGFR) \\< 30 ml/min/m2"}, 'identificationModule': {'nctId': 'NCT02244593', 'briefTitle': 'FAST MRI Study in Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'FAST MRI Study in Breast Cancer Survivors', 'orgStudyIdInfo': {'id': 'OHSN-REB 20140103-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Mammography screening only', 'description': 'This group will receive their standard of care mammogram only. Participants in this arm will not receive the FAST MRI.\n\nParticipants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.'}, {'type': 'EXPERIMENTAL', 'label': 'FAST MRI and mammogram screening', 'description': 'Patients in this group will receive Breast MRI and annual mammography. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram. The intervention is the addition of the FAST Breast MRI.', 'interventionNames': ['Other: FAST MRI and mammography screening']}], 'interventions': [{'name': 'FAST MRI and mammography screening', 'type': 'OTHER', 'otherNames': ['FAST MRI'], 'description': 'Patients in this group will receive Breast MRI and annual mammography. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.', 'armGroupLabels': ['FAST MRI and mammogram screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 9L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Jean Seely, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Planning on submitting preliminary results to RSNA 2017 and full publication by Oct 2018.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Jean Seely', 'investigatorFullName': 'Jean Seely', 'investigatorAffiliation': 'Ottawa Hospital Research Institute'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-01-13', 'type': 'RELEASE'}, {'date': '2023-11-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jean Seely, Dr. Jean Seely, Ottawa Hospital Research Institute'}}}}