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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Screen-detected Invasive Cancer Verified by Pathology
Secondary study objectives
Diagnostic Imaging
Change in Patient-reported Short-term Quality of Life Related to Diagnostic Testing
Factors Associated With Willingness to Return for Screening
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~3160
Contrast-enhanced Magnetic Resonance Imaging
2005
Completed Phase 1
~320
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,110,571 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
121 Previous Clinical Trials
178,681 Total Patients Enrolled
Christopher ComstockPrincipal InvestigatorECOG-ACRIN Cancer Research Group