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Preoperative Breast MRI for Breast Cancer

N/A

Waitlist Available

Led By Kimberly Van Zee, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age less than 60 at time of consent

Female

Must not have

Age 60 or over at time of consent

Patients with contraindications to breast conservation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the use of breast MRI in addition to mammography in women who have already been diagnosed with breast cancer to see if it can help find other areas of cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

MRI generally has few side effects but can include discomfort from lying still during the procedure, loud noises during scanning which may require ear protection, and rare allergic reactions to the contrast agent used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am under 60 years old.

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I am female.

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My breast surgery will be done at MSKCC.

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My breast cancer is in a very early stage, confirmed by a core biopsy.

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My cancer was diagnosed at an early stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am 60 years old or older.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI

2009

Completed Phase 2

~2810

0 / 8Eligibility criteria met