Breast MRI as a Preoperative Tool for DCIS

Breast Cancer Clinical Trial

Official title:

Breast MRI as a Preoperative Tool for DCIS

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00605982
• Other study ID #: 06-124
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 10, 2006
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ

Intervention

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).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center	Commack	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS.		conclusion of the study
Secondary	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
Secondary	To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI.		conclusion of the study
Secondary	To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning.		conclusion of the study
Secondary	To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI.		conclusion of the study

External Links

•   Memorial Sloan Kettering Cancer Center