Status:
COMPLETED
FAST MRI Study in Breast Cancer Survivors
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 wou...
Eligibility Criteria
Inclusion
- 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.
- Patients must have completed treatment for their breast cancer.
- 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)
- Patients who have undergone unilateral mastectomy or breast conservation surgery.
- Normal renal function: estimated glomerular filtration rate (eGFR) \> 30 ml/min/m2
Exclusion
- 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.
- Pregnant or breastfeeding patients.
- Patients who have had a breast MRI within the last 6 months.
- 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.
- Patients who have undergone bilateral mastectomies.
- Poor renal function: estimated glomerular filtration rate (eGFR) \< 30 ml/min/m2
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2020
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT02244593
Start Date
October 1 2014
End Date
September 25 2020
Last Update
September 28 2020
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 9L6