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

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

*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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Gadavist; Procedure: Magnetic Resonance Imaging (MRI)

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 Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants receiving care for breast cancer who also have a biopsy proven DCIS or ADH.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast Cancer patients; Adult, breast cancer patients with confirmed Ductal Carcinoma in Situ (DCIS) or atypical ductal hyperplasia (ADH)	Drug: Gadavist; Gadavist injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging; Other Names: Gadobutrol; Procedure: Magnetic Resonance Imaging (MRI); Undergo MRI; Other Names: MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Bonnie Joe, MD, PhD, University of California, San Francisco; Principal Investigator: Nola M. Hylton, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2008
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: December 5, 2008
• First Submitted That Met QC Criteria: December 5, 2008
• First Posted (Estimated): December 8, 2008

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ductal breast carcinoma in situ
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ; Carcinoma; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: CDR0000616972; 08755 (Other Identifier: University of California, San Francisco); NCI-2019-07528 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP)); R01CA116182 (U.S. NIH Grant/Contract); U01CA225427 (U.S. NIH Grant/Contract); R01CA249016 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No