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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804128
• Other study ID #: CDR0000616972
• Secondary ID: 08755NCI-2019-07
• Status: Completed
• Start date: October 1, 2008
• Est. completion date: January 5, 2024

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Procedure:
• Magnetic Resonance Imaging (MRI)
Undergo MRI

Drug:
• Gadavist
Gadavist injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of ductal carcinoma in situ (DCIS)-optimized MRI quality	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.	1 month
Primary	Comparison of two DCIS-optimized MRIs for variability in enhancement levels for DCIS	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.	1 month