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Contrast-Enhanced MRI in Women With Ductal Breast Carcinoma in Situ and in Healthy Volunteers

This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00804128
First received: December 5, 2008
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Procedure: contrast-enhanced magnetic resonance imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast-enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Comparison of 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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Comparison of two DCIS-optimized MRIs for variability in enhancement levels for DCIS, in terms of conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Effect of the menstrual cycle on the variability of background enhancement levels in normal stromal tissue as measured by the level of signal-enhancement-ratio [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2008
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

healthy volunteers Women with DCIS

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804128

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi     877-827-3222        
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nola M. Hylton, PhD University of California, San Francisco
Principal Investigator: Bonnie Joe, MD, PhD University of California, San Francisco
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00804128     History of Changes
Other Study ID Numbers: CDR0000616972, UCSF-H7987-32292-01B
Study First Received: December 5, 2008
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma, Ductal

ClinicalTrials.gov processed this record on May 23, 2013