Breast MRI as a Preoperative Tool for DCIS

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00605982

Collaborator

(none)

115

Enrollment

Locations

Arm

191.7

Duration (Months)

38.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Ductal Carcinoma in Situ	Procedure: MRI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Breast MRI as a Preoperative Tool for DCIS

Study Start Date :

Oct 10, 2006

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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).

Arm

Intervention/Treatment

Experimental: 1

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).

Outcome Measures

Primary Outcome Measures

To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS. [conclusion of the study]

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. [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 59 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Cancer Center	Basking Ridge	New Jersey	United States
2	Memorial Sloan Kettering Cancer Center	Commack	New York	United States	11725
3	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065