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

M.D. Anderson Cancer Center

Status and phase: Completed; Early Phase 1

Conditions: Breast Cancer

Treatments: Procedure: Short Breast MRI (SBMRI); Behavioral: Questionnaire

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02590458

NCI-2015-02031 (Registry Identifier)

2015-0243

Details and patient eligibility

About

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).

Full 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.

Enrollment: 131 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

131 participants in 1 patient group

Short Breast MRI (SBMRI)

Experimental group

Description:

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.

Treatment:

Behavioral: Questionnaire

Procedure: Short Breast MRI (SBMRI)