MRI Biopsy for Breast Cancer

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

31 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Breast MRI Biopsy for Breast Cancer?

Breast MRI can provide additional useful information that leads to changes in clinical management in about 30% of cases, with most changes being favorable. It helps in better defining the extent of surgery needed and assessing the effectiveness of nonsurgical therapy, although it may lead to more extensive surgery without proven long-term benefits. ^{1 2 3 4 5}

Is MRI biopsy for breast cancer safe?

Research on MRI-guided breast biopsies suggests that this procedure is generally safe, with studies focusing on its feasibility and safety in clinical settings. ^{6 7 8 9 10}

How is MRI-guided breast biopsy different from other breast cancer treatments?

MRI-guided breast biopsy is unique because it uses magnetic resonance imaging to precisely locate and sample suspicious breast tissue that may not be visible with other imaging methods like mammography or ultrasound. This technique allows for better detection and diagnosis of breast cancer, especially in complex cases or when the patient has dense breast tissue. ^{2 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to test the ability of a breast MRI biopsy to accurately diagnose a complete tumor response to the neoadjuvant chemotherapy (NAC) that the patient just finished. Numerous studies have shown that MRI has the highest accuracy for diagnosing a complete tumor response. The investigator wants to see if in a certain group of women who's breast cancer is no longer visible on the post-treatment MRI that the biopsy specimens from a MRI guided biopsy will accurately diagnose a complete tumor response to treatment which may in the future make breast surgery unnecessary in some women.

Research Team

Elizabeth Sutton, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Analysis of the effect of breast magnetic resonance imaging on the outcome in women undergoing breast conservation surgery with radiation therapy. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

MRI-guided core needle biopsy of the breast: Radiology-pathology correlation and impact on clinical management. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Role of magnetic resonance imaging in managing selected women with newly diagnosed breast cancer. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

The utility of breast MRI in the management of breast cancer. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Integration of breast magnetic resonance imaging with breast cancer treatment. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Time-Related Changes in Yield and Harms of Screening Breast Magnetic Resonance Imaging. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Breast MRI for cancer detection and characterization: a review of evidence-based clinical applications. [2008]

8. United States pubmed.ncbi.nlm.nih.gov

Outcomes Following Negative Screening MRI Results in Korean Women with a Personal History of Breast Cancer: Implications for the Next MRI Interval. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

MR-guided freehand biopsy of breast lesions in a 1.0-T open MR imager with a near-real-time interactive platform: preliminary experience. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Small masses on breast MR: is biopsy necessary? [2018]

11. United States pubmed.ncbi.nlm.nih.gov

MR intervention: indications, technique, correlation and histologic. [2010]

12. United States pubmed.ncbi.nlm.nih.gov

Breast magnetic resonance imaging for the interventionalist: magnetic resonance imaging-guided vacuum-assisted breast biopsy. [2014]

13. United States pubmed.ncbi.nlm.nih.gov

The emerging role of breast magnetic resonance imaging. [2005]

14. England pubmed.ncbi.nlm.nih.gov

MRI-guided breast biopsy: a review of technique, indications, and radiological-pathological correlations. [2019]