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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up conclusion of the study
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~conclusion of the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and conclusion of the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS.
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.
To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI.
To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI.
+1 more

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
~1370

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,692 Total Patients Enrolled
Kimberly Van Zee, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
1,460 Total Patients Enrolled

Media Library

MRI Clinical Trial Eligibility Overview. Trial Name: NCT00605982 — N/A
Ductal Carcinoma Research Study Groups: 1
Ductal Carcinoma Clinical Trial 2023: MRI Highlights & Side Effects. Trial Name: NCT00605982 — N/A
MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT00605982 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians eligible to participate in this experimental research?

"The trial is available to patients aged between 21 and 59. There are 1439 clinical trials for individuals over the age of 65, as well as 55 studies that accept participants below 18 years old."

Answered by AI

Could I be a participant in this clinical experiment?

"For this study, 115 individuals aged 21 to 59 with a diagnosis of breast cancer must meet the following qualifications: under 60 years old at time of agreement signature; Stage 0 or I T1mic upon evaluation; core biopsy results demonstrate DCIS and/or microinvasion (no more than .01 cm); planned surgical intervention completed at MSKCC prior to enrollment; informed consent obtained from participant; female."

Answered by AI

Are there any available slots for participants in this research endeavor?

"Per the clinicaltrials.gov listing, this particular research study is not currently open to participants. Initially posted on 10/10/2006 and last updated 11/7/2022, recruitment has temporarily ceased; however, there are still 1,513 other trials welcoming applicants at present."

Answered by AI
~3 spots leftby Oct 2024