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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Nola M. Hylton, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

CDR0000616972

NCT ID:

NCT00804128

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115