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

2014-08-27 03:25:49 | BioPortfolio

Summary

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.

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.

Study Design

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Diagnostic

Conditions

Breast Cancer

Intervention

contrast-enhanced magnetic resonance imaging

Location

UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco
California
United States
94115

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:25:49-0400

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