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

Early Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Short Breast MRI (SBMRI); Behavioral: Questionnaire

• Registration Number: NCT02590458
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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 Timeline

• Study Start: 2015-10-26
• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-29
• Status Verified: 2020-11
• Primary Completion: 2020-11-24
• Study Completion: 2020-11-24
• Last Update Submitted: 2020-11-28
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

1. 18 years and older female patients
2. BMRI indication: high risk screening per ACS guidelines
3. No contraindications to undergo MRI
4. Creatinine </=1.3 and GFR> 40
5. No requirement for sedation.

Exclusion Criteria

1. <18 years
2. Male
3. Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother
4. Contraindication to Gd contrast agents
5. Previous documented history of moderate to severe hypersensitivity to Gd contrast agents
6. Contraindications to MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Short Breast MRI (SBMRI)	Questionnaire	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.
Short Breast MRI (SBMRI)	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity of SBMRI for Detecting Breast Cancer in High Risk Participants	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.

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States