San Francisco, California 94115

  • Breast Cancer

Purpose:

RATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose ductal carcinoma in situ. PURPOSE: This randomized clinical trial is studying contrast-enhanced MRI in women with ductal breast carcinoma in situ and in healthy volunteers.


Study summary:

OBJECTIVES: - To compare ductal carcinoma in situ (DCIS)-optimized MRI with standard clinical MRI, in terms of conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality (i.e., artifact level, uniformity of fat suppression, contrast to noise ratio and signal to noise ratio), in women with DCIS of the breast. - To compare two DCIS-optimized MRIs for variability in enhancement levels for DCIS. - To examine the effect of the menstrual cycle on the variability of background enhancement levels in healthy volunteers. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms. - Arm I: Patients undergo standard clinical contrast-enhanced MRI over approximately 30-45 minutes. No more than 3 days later, patients undergo ductal carcinoma in situ (DCIS)-optimized contrast-enhanced MRI. - Arm II: Patients undergo DCIS-optimized contrast-enhanced MRI over approximately 30-45 minutes. No more than 3 days later, patients undergo a second DCIS-optimized contrast-enhanced MRI. Healthy volunteers undergo DCIS-optimized contrast-enhanced MRI as in arm II.


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 - Healthy volunteer - No prior 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)


Study is Available At:


Original ID:

CDR0000616972


NCT ID:

NCT00804128


Secondary ID:

UCSF-H7987-32292-01B


Study Acronym:


Brief Title:

Contrast-Enhanced MRI in Women With Ductal Breast Carcinoma in Situ and in Healthy Volunteers


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

90


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Nola M. Hylton, PhD
Principal Investigator
University of California, San Francisco

Study Dates

Start Date:October 2008
Completion Date:December 2024
Completion Type:Anticipated
Primary Completion Date:December 2024
Primary Completion Type:Anticipated
Verification Date:November 2019
Last Changed Date:November 22, 2019
First Received Date:December 5, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Effect of the menstrual cycle on the variability of background enhancement levels in normal stromal tissue as measured by the level of signal-enhancement-ratio
Time Frame:1 month
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Comparison of two DCIS-optimized MRIs for variability in enhancement levels for DCIS, in terms of conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality
Time Frame:1 month
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Comparison of ductal carcinoma in situ (DCIS)-optimized MRI with standard clinical MRI, in terms of conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality
Time Frame:1 month
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:contrast-enhanced magnetic resonance imaging

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

Study Population: healthy volunteers Women with DCIS
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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