Clinical trial NCT00605982: Breast MRI as a Preoperative Tool for DCIS
Official title: Breast MRI as a Preoperative Tool for DCIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Ductal Carcinoma in Situ
Keywords: MRI
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-01
Enrollment: 115
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS.
timeFrame: conclusion of the study
Secondary outcomes:
measure: 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.
timeFrame: conclusion of the study
measure: To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI.
timeFrame: conclusion of the study
measure: To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning.
timeFrame: conclusion of the study
measure: To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kimberly Van Zee, MD
role: PRINCIPAL_INVESTIGATOR
References: