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OpenTrials
Completed

NCT Number: NCT02590458

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: Survey

Primary outcomes

  1. Sensitivity of SBMRI for Detecting Breast Cancer in High Risk Participants

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • GE Healthcare

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2015
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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