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

Last updated: January 17, 2024
Sponsor: University of California, San Francisco
Overall Status: Completed

Phase

N/A

Condition

Carcinoma

Breast Cancer

Precancerous Condition

Treatment

contrast-enhanced magnetic resonance imaging

Gadavist

Magnetic Resonance Imaging (MRI)

Clinical Study ID

NCT00804128
CDR0000616972
R01CA249016
NCI-2019-07528
08755
R01CA116182
U01CA225427
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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)

Study Design

Total Participants: 76
Treatment Group(s): 3
Primary Treatment: contrast-enhanced magnetic resonance imaging
Phase:
Study Start date:
October 01, 2008
Estimated Completion Date:
January 05, 2024

Study 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.

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

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