Breast MRI as a Preoperative Tool for DCIS

NCT00605982 | Completed

• 1 other identifier: 06-124
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Breast Cancer; Ductal Carcinoma in Situ

Keywords

MRI

Outcome Measures

Primary Outcomes (1)

• To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS.

  conclusion of the study

Secondary Outcomes (4)

• 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.

  conclusion of the study

• To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI.

  conclusion of the study

• To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning.

  conclusion of the study

• To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI.

  conclusion of the study

Study Arms (1)

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

Interventions

MRI PROCEDURE

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).

1

Eligibility Criteria

• Age: 21 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (3)

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Cancer Center

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Kimberly Van Zee, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: February 1, 2008
• Study Start: October 10, 2006
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (3)