Preoperative Breast MRI for Breast Cancer

Recruiting at 3 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Age 60+, Pregnant, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

115 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Kimberly Van Zee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for women under 60 with a specific breast cancer diagnosis (DCIS or DCIS with microinvasion) who haven't had certain biopsies or surgeries yet. They must be able to have breast surgery at MSKCC and not be pregnant, nursing, or have conditions that make MRI unsafe like pacemakers, metal implants, severe weight over 350 lb., allergies to MRI contrast agents, or metal in the eye.

Inclusion Criteria

I am under 60 years old.

My breast surgery will be done at MSKCC.

I am female.

Exclusion Criteria

I am 60 years old or older.

I cannot have breast-saving surgery due to my condition.

I had a surgical biopsy for DCIS or DCIS with slight invasion before joining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative MRI Assessment

Participants undergo MRI to detect additional areas of cancer and assess treatment impact

1-2 weeks

1 visit (in-person)

Surgical Intervention

Participants undergo planned surgical intervention based on MRI findings

1 week

1 visit (in-person)

Follow-up

Participants are monitored for recurrence of breast cancer over a 10-year period

10 years

What Are the Treatments Tested in This Trial?

Interventions

• MRI

Trial Overview The study tests how effective Breast MRI is in detecting additional cancer areas in women already diagnosed with one area of breast cancer. It examines if the MRI influences treatment decisions and compares image findings with microscopic tissue analysis. Participants will also be followed for ten years to monitor cancer recurrence.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+