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Diagnostic Test

MRI + Mammography for Breast Cancer Screening

N/A
Waitlist Available
Led By Christopher Comstock
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must not be taking chemoprevention for breast cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing whether a combination of abbreviated breast MRI and digital tomosynthesis mammography is better at detecting cancer in women with dense breasts than digital tomosynthesis mammography alone.

Who is the study for?
This trial is for women with dense breasts who are due for routine screening, not pregnant or breastfeeding, and have no history of breast cancer or high-risk lesions. They mustn't be taking breast cancer prevention drugs, haven't had a breast MRI before, and can undergo an MRI with contrast. Women at high risk for breast cancer or those with certain health conditions like severe allergies to gadolinium or renal impairment are excluded.Check my eligibility
What is being tested?
The study is testing if abbreviated breast MRI—a quick, detailed imaging technique—and digital tomosynthesis mammography—a 3D X-ray of the breast—are effective in detecting cancer in women with dense breasts when used together compared to current standard screening methods.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still during the MRI procedure, reactions to the contrast agent used in MRIs such as mild allergic symptoms, anxiety from being in a confined space (claustrophobia), and exposure to radiation from mammography.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are not currently taking medication to prevent breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Screen-detected Invasive Cancer Verified by Pathology
Secondary outcome measures
Diagnostic Imaging
Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing
Ductal Carcinoma in Situ (DCIS) Detected on Abbreviated Breast-magnetic Resonance (MR) and Digital Tomosynthesis Mammography (DBT)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (AB-MR, DBT)Experimental Treatment4 Interventions
Participants undergo AB-MR for under 10 minutes followed by DBT on the same day or within 24 hours at baseline and then after 1year.
Group II: Arm A (DBT, AB-MR)Experimental Treatment4 Interventions
Participants undergo DBT followed by AB-MR for under 10 minutes on the same day or within 24 hours at baseline and then after 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital Tomosynthesis Mammography
2017
N/A
~140
Contrast-enhanced Magnetic Resonance Imaging
2005
Completed Phase 1
~320

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,931,637 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
175,406 Total Patients Enrolled
Christopher ComstockPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
JamaJournal
Comparison of Abbreviated Breast MRI Vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women with Dense Breasts Undergoing Screening
Comstock, Christopher E., Constantine Gatsonis, Gillian M. Newstead, Bradley S. Snyder, Ilana F. Gareen, Jennifer T. Bergin, Habib Rahbar, et al.. 2020. “Comparison of Abbreviated Breast MRI Vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women with Dense Breasts Undergoing Screening”. Jama. American Medical Association (AMA). doi:10.1001/jama.2020.0572.
clinicaltrials.govStudy
Abbreviated Breast MRI and Digital Tomosynthesis Mammography in Screening Women With Dense Breasts
2016. "Abbreviated Breast MRI and Digital Tomosynthesis Mammography in Screening Women With Dense Breasts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02933489.
~184 spots leftby Apr 2025
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