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:
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

December 5, 2008
May 9, 2013
October 2008
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 [ 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 [ 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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00804128 on ClinicalTrials.gov Archive Site
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Contrast-Enhanced MRI in Women With Ductal Breast Carcinoma in Situ and in Healthy Volunteers
Contrast-enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

healthy volunteers Women with DCIS

Breast Cancer
Procedure: contrast-enhanced magnetic resonance imaging
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Not Provided
December 2014   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
Yes
Not Provided
United States
 
NCT00804128
CDR0000616972, UCSF-H7987-32292-01B
No
University of California, San Francisco
University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Nola M. Hylton, PhD University of California, San Francisco
Principal Investigator: Bonnie Joe, MD, PhD University of California, San Francisco
University of California, San Francisco
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP