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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02590458
Recruitment Status : Active, not recruiting
First Posted : October 29, 2015
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Short Breast MRI (SBMRI) Behavioral: Questionnaire Early Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer
Actual Study Start Date : October 26, 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: SBMRI

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.
Other Name: Survey




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590458


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
GE Healthcare
Investigators
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Principal Investigator: Marion E. Scoggins, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02590458    
Other Study ID Numbers: 2015-0243
NCI-2015-02031 ( Registry Identifier: NCI CTRP )
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Short Breast MRI Scan
SBMRI
Routine MRI
High risk for breast cancer
Screening
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases