FAST MRI Study in Breast Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT02244593|
Recruitment Status : Recruiting
First Posted : September 19, 2014
Last Update Posted : April 11, 2018
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.
The 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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: FAST MRI and mammography screening||Not Applicable|
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.
The 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||FAST MRI Study in Breast Cancer Survivors|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||May 2020|
No Intervention: Mammography screening only
This group will receive their standard of care mammogram only. Participants in this arm will not receive the FAST MRI.
Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.
Experimental: FAST MRI and mammogram screening
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.
Other: FAST MRI and mammography screening
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.
Other Name: FAST MRI
- The percentage of patients with reduced anxiety as a result of having a FAST MRI [ Time Frame: up to 12 months ]
- Numbers of recurrent tumors in each arm [ Time Frame: 12 months ]
- Number of tumors missed by mammography [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244593
|Contact: Jean Seely, MD FRCPC||613-737-8899 ext firstname.lastname@example.org|
|Contact: Betty Anne Schwarz, RN BA MSc||613-798-5555 ext email@example.com|
|The Ottawa Hospital||Recruiting|
|Ottawa, Ontario, Canada, K1H 9L6|
|Principal Investigator: Jean Seely, MD FRCPC|
|Principal Investigator:||Jean Seely, MD FRCPC||Ottawa Hospital Research Institute|