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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590458
• Other study ID #: 2015-0243
• Secondary ID: NCI-2015-02031
• Status: Completed
• Phase: Early Phase 1
• Start date: October 26, 2015
• Est. completion date: November 24, 2020

Study information

• Verified date: November 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: November 24, 2020
• Est. primary completion date: November 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Behavioral:
• Questionnaire
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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   University of Texas MD Anderson Cancer Center Website