Breast MRI as a Preoperative Tool for DCIS

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer; Ductal Carcinoma in Situ

Treatments: Procedure: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT00605982

06-124

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 21 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Procedure: MRI