Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02590458|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2015
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Short Breast MRI (SBMRI) Behavioral: Questionnaire||Early Phase 1|
If you agree to take part in this study, you will have the short breast MRI scan (the scan for research purposes) with contrast on a different day than your scheduled routine MRI screening scan with contrast. You will have your routine scan the first day and the research scan at least 1 day after. The research scan will take about 10 minutes to complete.
After your short breast MRI scan is completed, you will complete a questionnaire about your comfort level and experience of the research scan. It should take about 10 minutes to complete the questionnaire.
This is an investigational study. The short breast MRI is considered investigational.
Up to 200 participants will be enrolled in this study. All will be enrolled at MD Anderson.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer|
|Actual Study Start Date :||October 26, 2015|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2021|
Experimental: Short Breast MRI (SBMRI)
Routine scheduled MRI with contrast performed on women at high risk of developing breast cancer. One day after routine MRI, short breast MRI (SBMRI) with contrast performed. After SBMRI, participant completes a questionnaire about their comfort level and experience of the research scan.
Procedure: Short Breast MRI (SBMRI)
One day after routine MRI, short breast MRI (SBMRI) with contrast performed. Scan will take about 10 minutes to complete.
Other Name: SBMRI
After SBMRI, participant completes a questionnaire about their comfort level and experience of the research scan. It should take about 10 minutes to complete the questionnaire.
Other Name: Survey
- Sensitivity of SBMRI for Detecting Breast Cancer in High Risk Participants [ Time Frame: 1 day ]Radiologists blinded to patient outcome review images from each study independently and rate the possibility of breast cancer using BI-RADS score. BIRADS 0, 3,4, 5 considered positive, BIRADS 1 and 2 considered negative results for the analysis. Each reader's score for a given case assessed both independently and on a separate session, as consensus.
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): NCT02590458
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Marion E. Scoggins, MD||M.D. Anderson Cancer Center|