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

a study on Breast Cancer Carcinoma

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Nola M. Hylton, PhDBonnie Joe, MD, PhD
Headshot of Nola M. Hylton
Nola M. Hylton
Headshot of Bonnie Joe
Bonnie Joe

Description

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.

Official Title

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

Details

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.

Keywords

Breast Cancer, ductal breast carcinoma in situ, Carcinoma, Carcinoma in Situ, Ductal Carcinoma, Carcinoma, Intraductal, Noninfiltrating, contrast-enhanced magnetic resonance imaging, Gadavist

Eligibility

For females ages 18 years and up

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)

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientists at UCSF

  • Nola M. Hylton, PhD
    Nola Hylton, PhD, is a Professor in Residence in the Department of Radiology and Biomedical Imaging, and Director of the Breast Imaging Research Group at the University of California, San Francisco.
  • Bonnie Joe, MD, PhD
    Bonnie N. Joe, MD, PhD, is a Professor in Residence and Chief of Breast Imaging in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco. Developing a breat imaging program was a natural progression of Dr. Joe’s research interest in breast MRI, female pelvic MRI, and fetal MRI.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT00804128
Study Type
Observational
Participants
Expecting 120 study participants
Last Updated
Contact us about this trial