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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00804128
Recruitment Status : Recruiting
First Posted : December 8, 2008
Last Update Posted : May 4, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

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
Breast Cancer 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.

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Study Type : Observational
Estimated 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 : October 1, 2008
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Gadobutrol


Intervention Details:
  • Procedure: contrast-enhanced magnetic resonance imaging
  • Drug: Gadavist
    Gadavist injection is a paramagnetic macrocyclic contrast agent administered for magnetic resonance imaging
    Other Name: Gadobutrol


Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with biopsy proven DCIS Subjects with ADH.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804128


Contacts
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Contact: Nola Hylton, PhD 877-827-3222 cancertrials@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Margarita Watkins    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Nola Hylton, PhD         
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nola M. Hylton, PhD University of California, San Francisco
Principal Investigator: Bonnie Joe, MD, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00804128    
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 )
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ