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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Gadavist; Procedure: Magnetic Resonance Imaging (MRI)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00804128

R01CA116182 (U.S. NIH Grant/Contract)

R01CA249016 (U.S. NIH Grant/Contract)

08755 (Other Identifier)

U01CA225427 (U.S. NIH Grant/Contract)

CDR0000616972

NCI-2019-07528 (Registry Identifier)

Details and patient eligibility

About

*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.

Full description

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.

Enrollment: 76 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

76 participants in 1 patient group

Breast Cancer patients

Description:

Adult, breast cancer patients with confirmed Ductal Carcinoma in Situ (DCIS) or atypical ductal hyperplasia (ADH)

Treatment:

Drug: Gadavist

Procedure: Magnetic Resonance Imaging (MRI)