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

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Magnetic Resonance Imaging (MRI); Drug: Gadavist

• Registration Number: NCT00804128
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2008-10-01
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Status Verified: 2024-01
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-05
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Cancer patients	Magnetic Resonance Imaging (MRI)	Adult, breast cancer patients with confirmed Ductal Carcinoma in Situ (DCIS) or atypical ductal hyperplasia (ADH)
Breast Cancer patients	Gadavist	Adult, breast cancer patients with confirmed Ductal Carcinoma in Situ (DCIS) or atypical ductal hyperplasia (ADH)

Primary Outcome Measures

Name	Time	Method
Comparison of ductal carcinoma in situ (DCIS)-optimized MRI quality	1 month	Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image quality for each MRI.
Comparison of two DCIS-optimized MRIs for variability in enhancement levels for DCIS	1 month	Conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality will be used to determine the overall image variability for each MRI.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States