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

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT00804128
Collaborator
National Cancer Institute (NCI) (NIH)
120
Enrollment
1
Location
195
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: contrast-enhanced magnetic resonance imaging
  • Drug: Gadavist

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 Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Contrast-enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)
Actual Study Start Date :
Oct 1, 2008
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

  • Patient 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:

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94143

Sponsors and Collaborators

  • University of California, San Francisco
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Nola M. Hylton, PhD, University of California, San Francisco
  • Principal Investigator: Bonnie Joe, MD, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00804128
Other Study ID Numbers:
  • CDR0000616972
  • 08755
  • NCI-2019-07528
  • R01CA116182
  • U01CA225427
First Posted:
Dec 8, 2008
Last Update Posted:
Dec 15, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by University of California, San Francisco
ductal breast carcinoma in situ
Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating

Study Results

No Results Posted as of Dec 15, 2021