Summary

for females ages 18 years and up (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion
Nola M. Hylton, PhDBonnie Joe, MD, PhD

Description

Summary

RATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose ductal carcinoma in situ.

PURPOSE: This randomized clinical trial is studying contrast-enhanced MRI in women with ductal breast carcinoma in situ and in healthy volunteers.

Official Title

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

Details

OBJECTIVES:

  • To compare ductal carcinoma in situ (DCIS)-optimized MRI with standard clinical MRI, in terms of conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality (i.e., artifact level, uniformity of fat suppression, contrast to noise ratio and signal to noise ratio), in women with DCIS of the breast.
  • To compare two DCIS-optimized MRIs for variability in enhancement levels for DCIS.
  • To examine the effect of the menstrual cycle on the variability of background enhancement levels in healthy volunteers.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.

  • Arm I: Patients undergo standard clinical contrast-enhanced MRI over approximately 30-45 minutes. No more than 3 days later, patients undergo ductal carcinoma in situ (DCIS)-optimized contrast-enhanced MRI.
  • Arm II: Patients undergo DCIS-optimized contrast-enhanced MRI over approximately 30-45 minutes. No more than 3 days later, patients undergo a second DCIS-optimized contrast-enhanced MRI.

Healthy volunteers undergo DCIS-optimized contrast-enhanced MRI as in arm II.

Keywords

Breast Cancer ductal breast carcinoma in situ Carcinoma Carcinoma in Situ Breast Carcinoma In Situ contrast-enhanced magnetic resonance imaging

Eligibility

For females ages 18 years and up

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:
  • Patient 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
  • Healthy volunteer
  • No prior breast disease

PATIENT CHARACTERISTICS:

  • 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 Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States

Lead Scientists

  • 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
Last Updated