Clinical trial NCT00804128: Contrast-Enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)
Official title: Contrast-enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-12-08
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants receiving care for breast cancer who also have a biopsy proven DCIS or ADH.

Brief summary: \*REFERRALS TO THIS TRIAL MUST BE THROUGH BREAST CARE CLINICIANS ONLY\*

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

PURPOSE: This study is to develop and refine magnetic resonance (MR) imaging methods for pre-operative staging of ductal carcinoma in situ, a pre-invasive form of breast cancer, and atypical ductal hyperplasia, a risk factor for developing cancer.

Detailed description: OBJECTIVES:

* Compare the DCIS optimized MRI to the standard clinical MRI. Using a scale of 1-5 from poor to excellent, images will be assessed for conspicuity of DCIS and atypical ductal hyperplasia (ADH) lesions, agreement of disease extent with biopsy, and overall image quality (artifact level, uniformity of fat suppression, contrast to noise ratio and signal to noise ratio).
* Subjects with ADH, a benign condition that can also show enhancement on MRI, will be enrolled to explore the utility of the DCIS optimized MRI for distinguishing DCIS and ADH.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Patients 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.
    * ADH patients: over 18, no prior history of breast disease.

PATIENT CHARACTERISTICS:

* Referrals to this trial are through breast care clinicians only
* 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)

Primary outcomes:
measure: Comparison of ductal carcinoma in situ (DCIS)-optimized MRI quality
timeFrame: 1 month
measure: Comparison of two DCIS-optimized MRIs for variability in enhancement levels for DCIS
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Nola M. Hylton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Bonnie Joe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: