Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer

Study Overview
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Brief Summary
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The goal of this clinical research study is to test if a short breast MRI scan (about 10 minutes) can be used for breast cancer screening in high risk people and to learn if it is as effective as a routine breast MRI scan (30-60 minutes).

Detailed Description
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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.

Official Title
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Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Short Breast MRI (SBMRI)
* Behavioral: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older female patients BMRI indication: high risk screening per ACS guidelines No contraindications to undergo MRI Creatinine </=1.3 and GFR> 40 No requirement for sedation. Exclusion Criteria: <18 years Male Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother Contraindication to Gd contrast agents Previous documented history of moderate to severe hypersensitivity to Gd contrast agents Contraindications to MRI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short Breast MRI (SBMRI)<br>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)<br>* One day after routine MRI, short breast MRI (SBMRI) with contrast performed. Scan will take about 10 minutes to complete.<br>* Other names: SBMRI;Behavioral: Questionnaire<br>* 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.<br>* Other names: Survey;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of SBMRI for Detecting Breast Cancer in High Risk Participants | 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Short Breast MRI Scan, SBMRI, Routine MRI, High risk for breast cancer, Screening