Active — Not RecruitingNot Applicable

MRI Characterization of Mammographically Detected DCIS

United States122 participantsStarted 2018-04-20

Plain-language summary

This is a single institution, prospective observational clinical trial for women with mammographically identified calcifications that may represent ductal carcinoma in situ (DCIS). The purpose of this study is to determine whether quantitative, multiparametric breast MRI performed prior to surgical resection can biologically characterize this common pre-invasive malignancy, ductal carcinoma in situ (DCIS), which typically presents in asymptomatic women as suspicious calcifications on mammography.

Who can participate

Age range18 Years – 80 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Fractional perfusion (f)

Timeframe: 3.5 years

Tissue diffusion (Dt)

Timeframe: 3.5 years

Transfer constant (Ktrans)

Timeframe: 3.5 years

Trial details

NCT IDNCT03495011

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-30

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