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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of California, San Francisco.
Recruitment status was:  Recruiting
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: December 15, 2014
Last verified: December 2014

December 5, 2008
December 15, 2014
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 ]
  • 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 ]
  • 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 ]
  • 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
  • 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
  • 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
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.
 
Unknown status
90
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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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00804128
CDR0000616972
UCSF-H7987-32292-01B
No
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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
December 2014

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