Breast MRI as a Preoperative Tool for DCIS - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00605982

Purpose

Breast MRI is a fairly new technology, but it has been well studied. It is now used routinely in many patients with breast cancer. It has been shown to be useful in detecting areas of cancer that cannot be seen using other types of scans or tests.

The purpose of this study is to see how often MRI can find other areas of cancer in women with one area of breast cancer, and to determine how having the MRI test affects their treatment. The purpose is also to study any areas of abnormality seen on your MRI with special methods that allow the images of your breast tissue and the microscopic analysis of your breast tissue to be compared very carefully. The study also aims to follow women who enter the study over a 10-year period to determine how often the breast cancer comes back.

Condition	Intervention
Breast Cancer Ductal Carcinoma In Situ	Procedure: MRI

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Breast MRI as a Preoperative Tool for 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 Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the proportion of all patients in this study in whom breast MRI identifies at least one site of cancer separate from the index lesion. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Enrollment:	115
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Women with core biopsy proven DCIS with or without microinvasion seen for surgical consultation at Memorial Sloan-Kettering Cancer Center and for whom operative intervention is planned.	Procedure: MRI The patient will then undergo a breast MRI as part of their preoperative work-up of DCIS. Biopsy of any suspicious areas by needle biopsy or at the time of surgery. If appropriate, repeat MRI after biopsy or surgery. Follow-up for 10 years (you will be contacted once a year to see how you are doing).

Eligibility

Ages Eligible for Study:	21 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age less than 60 at time of consent
Clinical stage is consistent with Stage 0 or Stage I T1mic at presentation
Core biopsy proven DCIS or DCIS with microinvasion (invasion ≤0.1 cm), prior to enrollment
Breast surgery to be performed at MSKCC
Informed consent obtained
Female

Exclusion Criteria:

Age 60 or over at time of consent
Patients who are pregnant or nursing
Patients with contraindications to breast conservation
Excisional biopsy of DCIS or DCIS with microinvasion, prior to enrollment
Patients with any contraindications to MRI including pacemaker, tissue expander, other metallic surgical implants, weight over 350 lb., previous gadolinium reaction, metal fragments in eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605982

Locations

United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center
Commack, New York, United States, 11725

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Kimberly Van Zee, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Kimberly Van Zee, MD )
Study ID Numbers:	06-124
Study First Received:	January 21, 2008
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00605982 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

MRI

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 November 27, 2009