Can MRI spot dangerous breast calcifications without a biopsy?
NCT ID NCT03495011
First seen Jun 25, 2026 · Last updated Jul 22, 2026 · Updated 3 times
Summary
This study looks at whether advanced breast MRI can tell the difference between harmless and dangerous breast calcifications, which are often a sign of very early-stage breast cancer called DCIS. About 122 women with suspicious calcifications or recent DCIS diagnosis will get an MRI before surgery. The goal is to see if MRI features match up with lab tests that show how aggressive the cancer might be, which could lead to better, less invasive diagnosis in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors better understand which breast calcifications are dangerous, potentially reducing unnecessary biopsies.
- What could go wrong
- This is an observational study, not a treatment trial. It may not lead to immediate changes in patient care, and results may not apply to all women.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
122 people
The number who actually took part.
- Started
-
Apr 2018
- Expected to finish
-
Apr 2032
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Women aged 18 or older with suspicious mammographic caclifications or biopsy-proven DCIS with residual calcifications present on mammogram after biopsy. Study participants will undergo an experimental 3 Tesla breast MRI prior to surgical resection, including both DWI and DCE techniques. Only participants who are diagnosed with pure DCIS on both core needle biopsy and surgical resection will remain on study. Tissue from all DCIS lesions will also be sent for outside multi-gene assay testing (Oncotype DX DCIS score, Genomic Health, Redwood City, CA).
- Ages
-
18 to 80 years
- Sex
-
Female participants only
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * \[Cohort A\] Women aged 18 or older with suspicious calcifications identified on mammography without an associated mass * \[Cohort B\] Women aged 18 or older with recent biopsy-proven DCIS with residual calcifications present on mammogram after biopsy Exclusion Criteria for Both Cohorts: * Patients with prior history of breast cancer in the ipsilateral breast * Patients with a newly diagnosed breast cancer in the contralateral breast * Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with GFR\<60, contrast allergy, incompatible metal) * Patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators) * Women who are pregnant
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer stage 0 are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.