MRI Biopsy for Breast Cancer

Not currently recruiting at 11 trial locations

Overseen By Mahmoud El-Tamer, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Prior breast cancer, Pregnancy, Breastfeeding, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a breast MRI biopsy, an imaging test, can accurately confirm if breast cancer has fully responded to chemotherapy. The researchers aim to determine if surgery might be unnecessary for some women when the MRI shows no signs of the tumor after treatment. This could benefit women who have completed chemotherapy and show no visible breast cancer on their MRI.

As an unphased study, this trial provides a unique opportunity for patients to contribute to research that could potentially reduce the need for surgery in the future.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this MRI biopsy is safe for diagnosing breast cancer?

Research has shown that MRI-guided breast biopsies are generally safe. They do not use radiation, making them a safer option for examining breast conditions. Studies have found that these biopsies are a quick and safe choice when a suspicious area is only visible on an MRI.

However, like any medical procedure, some risks exist. Common issues include bruising, swelling, or bleeding at the biopsy site. Some individuals might also experience pain or soreness afterward. Despite these risks, patients usually tolerate MRI-guided breast biopsies well, and they effectively diagnose breast conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MRI biopsy technique for breast cancer because it offers a potential breakthrough in accurately assessing tumor response after chemotherapy. Unlike traditional biopsies, which may rely on ultrasound or mammography, this method uses MRI guidance to precisely target and sample the tumor area. This could lead to a more accurate assessment of how well a tumor has responded to treatment, potentially reducing the need for more invasive surgical procedures. By refining the way doctors evaluate cancer treatment effectiveness, this approach could personalize and improve care for breast cancer patients.

What evidence suggests that this MRI biopsy is effective for diagnosing a complete tumor response in breast cancer?

Research has shown that MRI-guided breast biopsies effectively diagnose breast conditions with high accuracy. Studies indicate that the procedure succeeds over 99% of the time. It also has a low false-negative rate of just 0.4%, minimizing the chance of missing a diagnosis. For women at high risk of breast cancer, MRI results lead to a 43% likelihood that the biopsy will confirm the findings, indicating a strong correlation between the biopsy and MRI results. In this trial, all participants will undergo an MRI-guided biopsy to assess if breast cancer has fully responded to chemotherapy, demonstrating that MRI-guided biopsies are a reliable method for this evaluation. ^{6 7 8 9 10}

Who Is on the Research Team?

Elizabeth Sutton, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I will have surgery at MSKCC soon after my chemotherapy ends.

I am a woman aged 18 or older.

Exclusion Criteria

I have had breast cancer before and received treatment for it.

Any underlying medical or psychiatric conditions, which in the opinion of the investigator, will make performing the study intervention hazardous or obscure the interpretation of the results

I have had breast cancer surgery or radiotherapy in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants undergo neoadjuvant chemotherapy prior to MRI biopsy

Varies

MRI Biopsy

Participants undergo percutaneous MR guided biopsy to evaluate tumor response

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after MRI biopsy

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Breast MRI Biopsy

Trial Overview 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.

How Is the Trial Designed?

Group I: MRI biopsy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 320 high-risk women who underwent 757 breast MRI procedures from 2007 to 2013, the number of false-positive findings (harms) decreased with each subsequent MRI, indicating improved screening efficiency over time.

Despite the initial higher rate of false positives, breast MRI continued to successfully detect cancer, with a total of 6 malignancies identified from 75 biopsy procedures, demonstrating its ongoing utility as a screening tool for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Related Changes in Yield and Harms of Screening Breast Magnetic Resonance Imaging. Pederson, HJ., O'Rourke, C., Lyons, J., et al.[2015]

Breast MRI is particularly beneficial for high-risk patients, those with a new breast cancer diagnosis, and for monitoring treatment responses, showing high sensitivity for earlier and more accurate cancer detection.

Despite its advantages, breast MRI has limitations such as high costs and modest specificity, which can lead to false positives, highlighting the need for careful application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast MRI for cancer detection and characterization: a review of evidence-based clinical applications. DeMartini, W., Lehman, C., Partridge, S.[2008]

In a study of 493 breast cancer patients, MRI provided additional clinical information in 52.9% of cases, leading to changes in management for 44.3% of patients, with 83.9% of those changes deemed appropriate.

While MRI can enhance clinical decision-making, it often results in more extensive surgeries (40% of cases) without demonstrating a clear prognostic benefit, suggesting it should be used selectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of magnetic resonance imaging in managing selected women with newly diagnosed breast cancer. Scomersi, S., Urbani, M., Tonutti, M., et al.[2010]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9806944/

A Systematic Review and Meta-Analysis MRI-guided breast biopsy is an efficient, highly accurate technique with high technical success [99.10%, 95% confidence interval (CI): 97.89–99.62%]

2. eurjbreasthealth.com eurjbreasthealth.com/articles/performance-benchmark-metrics-and-clinicopathologic-outcomes-of-mri-guided-breast-biopsies-a-systematic-review-and-meta-analysis/ejbh.galenos.2022.2022-12-1

A Systematic Review and Meta-Analysis MRI-guided breast biopsy is an efficient, highly accurate technique with high technical success [99.10%, 95% confidence interval (CI): 97.89–99.62%]

3. ajronline.org ajronline.org/doi/10.2214/AJR.07.2827

Outcome of MRI-Guided Breast Biopsy | AJR A recent study of MRI in women at high risk for breast cancer showed a 43% positive predictive value for biopsies performed as a result of MRI findings [17]. ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820924001757

Clinical Outcomes of Benign Concordant MRI-Guided ... Breast MRI-guided biopsy has a low false-negative rate. Our single malignancy from a total of 275 lesions gives a false negative rate of 0.4%.

5. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-025-01990-y

Cost-effectiveness of contrast-enhanced breast MRI in ... Breast MRI and stereotactic biopsy yield comparable cost-effectiveness and clinical outcomes. Breast MRI should be considered as an option ...

6. mayoclinic.org mayoclinic.org/tests-procedures/breast-biopsy/about/pac-20384812

Breast biopsy Risks · Bruising and swelling of the breast · Infection or bleeding at the biopsy site · Altered breast appearance, depending on how much tissue is ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4361320/

MRI-guided Breast Biopsy: Outcomes and Impact on Patient ... When a suspicious lesion is visible only on MRI, MRI-guided biopsy is a fast and safe option for diagnosis. The reported malignancy rate of MRI-guided breast ...

8. my.clevelandclinic.org my.clevelandclinic.org/health/diagnostics/24204-breast-biopsy-overview

Breast Biopsy: Types, Procedure, Recovery & Results What are the risks of a breast biopsy? There are some common risks and side effects, including: Bruising · Bleeding; Swelling; Pain or soreness; Surgical wound ...

9. radiologyinfo.org radiologyinfo.org/en/info/breastbimr

MR-Guided Breast Biopsy Biopsy markers are MRI compatible and will not cause metal detectors to alarm. Avoid strenuous activity for at least 24 hours after the biopsy. Your doctor will ...

10. upmc.com upmc.com/services/imaging/services/womens/mri-guided-breast-biopsy

MRI-Guided Breast Biopsy: Before, During, and After Your ... MRI-guided breast biopsies do not use radiation, making them a safe option for accurately evaluating a range of breast conditions. When compared ...