Contrast-Enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)

University of California, San Francisco76 enrolled

Overview

\*REFERRALS TO THIS TRIAL MUST BE THROUGH BREAST CARE CLINICIANS ONLY\* RATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose ductal carcinoma in situ. PURPOSE: This study is to develop and refine magnetic resonance (MR) imaging methods for pre-operative staging of ductal carcinoma in situ, a pre-invasive form of breast cancer, and atypical ductal hyperplasia, a risk factor for developing cancer.

OBJECTIVES: * Compare the DCIS optimized MRI to the standard clinical MRI. Using a scale of 1-5 from poor to excellent, images will be assessed for conspicuity of DCIS and atypical ductal hyperplasia (ADH) lesions, agreement of disease extent with biopsy, and overall image quality (artifact level, uniformity of fat suppression, contrast to noise ratio and signal to noise ratio). * Subjects with ADH, a benign condition that can also show enhancement on MRI, will be enrolled to explore the utility of the DCIS optimized MRI for distinguishing DCIS and ADH.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer

Interventions

Magnetic Resonance Imaging (MRI)PROCEDURE

Undergo MRI

GadavistDRUG

Gadavist injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Patients at the University of California, San Francisco Breast Care Center meeting the following criteria: * Biopsy proven ductal carcinoma in situ (DCIS) of the breast. * Has undergone mammography within the past 60 days. * ADH patients: over 18, no prior history of breast disease. PATIENT CHARACTERISTICS: * Referrals to this trial are through breast care clinicians only * Not pregnant or nursing (or stopped nursing within the past 3 months) * Negative pregnancy test * No contraindication to MRI (e.g., implanted pacemaker, implanted ferromagnetic device, ferromagnetic aneurysm clip, severe claustrophobia, ocular metal fragments, or shrapnel injury) PRIOR CONCURRENT THERAPY: * More than 2 years since prior surgery to the ipsilateral breast (patient) * No prior radiotherapy to the ipsilateral breast (patient) * No prior cytotoxic regimens (patient)

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Comparison of ductal carcinoma in situ (DCIS)-optimized MRI quality

Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image quality for each MRI.

Time frame: 1 month

Comparison of two DCIS-optimized MRIs for variability in enhancement levels for DCIS

Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image variability for each MRI.

Time frame: 1 month

Data from ClinicalTrials.gov

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