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

Sponsor:	University of California, San Francisco
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00804128

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.

Condition	Intervention
Breast Cancer	Procedure: contrast-enhanced magnetic resonance imaging

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind
Official Title:	Contrast-Enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	October 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804128

Locations

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center	Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222

Sponsors and Collaborators

University of California, San Francisco

National Cancer Institute (NCI)

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCSF Helen Diller Family Comprehensive Cancer Center ( Nola M. Hylton )
Study ID Numbers:	CDR0000616972, UCSF-H7987-32292-01B
Study First Received:	December 5, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00804128 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

ductal breast carcinoma in situ

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Skin Diseases
Breast Neoplasms
Carcinoma
Carcinoma, Ductal
Neoplasms
Neoplasms by Site

Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010