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MRI Biopsy for Breast Cancer

Q: How many facilities are administering the trial presently?

The investigation is currently underway at 12 distinct clinics, located in Commack, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> and Montvale amongst other places. To make the experience more convenient for participants, it is encouraged to enrol at a center close by.

Q: Is this study currently open to enrollment?

According to the data featured on clinicaltrials.gov, this trial is currently recruiting participants. It was first posted in September 2017 and has been updated as recently as November 2022.

Q: What is the current sample size of this trial?

Affirmative, clinicaltrials.gov has listed this medical trial as actively recruiting patients since its initial posting on September 18th of 2017. The latest update was made on November 23rd 2022 and the study is looking for 45 participants to be recruited from 12 distinct sites.

N/A

Waitlist Available

Led By Elizabeth Sutton, 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

No indication of distant metastases (M0)

Confirmed histologic diagnosis of operable HER2 overexpressing (ER<10%, PR<10%, and HER2 2+ or FISH amplified) OR triple negative (ER<10%, PR<10%, and HER2 0/1+ or 2+/FISH not amplified) OR ER positive invasive ductal or invasive lobular breast cancer including MSKCC pathology confirmation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing if MRI-guided biopsies can accurately tell if a patient's breast cancer has disappeared after neoadjuvant chemotherapy, potentially avoiding the need for surgery.

Who is the study for?

This trial is for women over 18 with certain types of breast cancer (HER2 overexpressing, triple negative, or ER positive) who have completed neoadjuvant chemotherapy and show no signs of the tumor on MRI. They must not be pregnant or breastfeeding, have a good performance status score, no distant metastases, and be scheduled for definitive surgery at MSKCC within 60 days.Check my eligibility

What is being tested?

The study tests if an MRI biopsy can accurately confirm complete tumor disappearance after chemotherapy in breast cancer patients. This could potentially eliminate the need for surgery in some cases by using post-treatment MRIs to guide biopsies.See study design

What are the potential side effects?

While specific side effects are not listed for an MRI-guided biopsy procedure itself, common risks may include discomfort at the biopsy site, bruising, bleeding or infection.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has not spread to distant parts of my body.

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My breast cancer is confirmed as HER2 positive, triple negative, or ER positive.

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I am mostly self-sufficient and can carry out daily activities.

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I am not pregnant and can have children.

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My breast cancer is operable, and after treatment, an MRI showed no signs of the tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Magnetic Resonance Imaging

Trial Design

1Treatment groups

Experimental Treatment

Group I: MRI biopsyExperimental Treatment1 Intervention

All patients enrolled will have had complete MR imaging response post Neoadjuvant Chemotherapy (NAC) and will undergo percutaneous MR guided biopsy.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,591 Total Patients Enrolled

202 Trials studying Breast Cancer

81,106 Patients Enrolled for Breast Cancer

Elizabeth Sutton, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

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

How many facilities are administering the trial presently?

"The investigation is currently underway at 12 distinct clinics, located in Commack, New york and Montvale amongst other places. To make the experience more convenient for participants, it is encouraged to enrol at a center close by."

Answered by AI

Is this study currently open to enrollment?

"According to the data featured on clinicaltrials.gov, this trial is currently recruiting participants. It was first posted in September 2017 and has been updated as recently as November 2022."

Answered by AI

What is the current sample size of this trial?

"Affirmative, clinicaltrials.gov has listed this medical trial as actively recruiting patients since its initial posting on September 18th of 2017. The latest update was made on November 23rd 2022 and the study is looking for 45 participants to be recruited from 12 distinct sites."

Answered by AI

Recent research and studies

JAMA Network OpenJournal

Accuracy of Magnetic Resonance Imaging–guided Biopsy to Verify Breast Cancer Pathologic Complete Response After Neoadjuvant Chemotherapy

Sutton, Elizabeth J., Lior Z. Braunstein, Mahmoud B. El-Tamer, Edi Brogi, Mary Hughes, Yolanda Bryce, Jill S. Gluskin, et al.. 2021. “Accuracy of Magnetic Resonance Imaging–guided Biopsy to Verify Breast Cancer Pathologic Complete Response After Neoadjuvant Chemotherapy”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2020.34045.

clinicaltrials.govStudy

Evaluate The Accuracy Of Breast MRI Biopsy In Diagnosing A Complete Tumor Response For Some Women Following Neoadjuvant Chemotherapy For Breast Cancer

2017. "Evaluate The Accuracy Of Breast MRI Biopsy In Diagnosing A Complete Tumor Response For Some Women Following Neoadjuvant Chemotherapy For Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03289195.

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