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

NCT ID: NCT02590458

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-26

Study Completion Date

2020-11-24

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Short Breast MRI (SBMRI)

Intervention Type PROCEDURE

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

Questionnaire

Intervention Type 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.

Interventions

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Short Breast MRI (SBMRI)

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

Intervention Type PROCEDURE

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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SBMRI Survey

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marion E. Scoggins, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2015-02031

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-0243

Identifier Type: -

Identifier Source: org_study_id