Skip to main content
OpenTrials
Completed

NCT Number: NCT00804128

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Procedure

Undergo MRI

Other names: MRI

Gadavist

Drug

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

Other names: Gadobutrol

Primary outcomes

  1. Comparison of ductal carcinoma in situ (DCIS)-optimized MRI quality

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2008
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2008
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.