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

NCT02590458 | Completed Early Phase 1

• 2 other identifiers: 2015-0243NCI-2015-02031
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

Breast Cancer; Short Breast MRI Scan; SBMRI; Routine MRI; High risk for breast cancer; Screening

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Short Breast MRI (SBMRI)

EXPERIMENTAL

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); Behavioral: Questionnaire

Interventions

Short Breast MRI (SBMRI) PROCEDURE

One day after routine MRI, short breast MRI (SBMRI) with contrast performed. Scan will take about 10 minutes to complete.

Also known as: SBMRI

Short Breast MRI (SBMRI)

Questionnaire BEHAVIORAL

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.

Also known as: Survey

Short Breast MRI (SBMRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• GE Healthcare: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marion E. Scoggins, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 29, 2015
• Study Start: October 26, 2015
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

US (1)