MBI-Guided Biopsy for Breast Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Breastfeeding, Breast implants, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well molecular breast imaging (MBI) can guide breast biopsies for those with suspicious breast findings. Traditional methods like ultrasound or mammography sometimes miss parts of a lesion, reducing biopsy accuracy. MBI may help doctors see breast tumors more clearly, leading to better biopsy results. This trial suits women who had a breast imaging test in the past three years showing a benign finding and now have a new breast abnormality needing further evaluation. Participants will receive a special dye and undergo MBI. If any areas of interest appear, a biopsy will be performed using this advanced imaging technique. As an unphased trial, this study allows participants to contribute to advancing breast imaging techniques for more accurate diagnoses.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulant medication (blood thinners), you must be willing to stop using them before the procedure.

What prior data suggests that this MBI-guided biopsy technique is safe for breast cancer patients?

Research has shown that molecular breast imaging (MBI) can detect more breast cancers, particularly in women with dense breast tissue. MBI uses a small amount of a radioactive substance to create breast images. Some studies found that MBI can identify additional cancers that other methods might miss.

However, there is a trade-off. The radiation dose from MBI exceeds that of a regular mammogram, slightly increasing the risk of radiation-related cancer, though this risk remains low.

Overall, MBI is generally well-tolerated and has demonstrated improved breast cancer detection in certain cases. Prospective trial participants should weigh the benefits of better detection against the small increase in radiation exposure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MBI-guided biopsy for breast cancer because it offers a new way to detect and biopsy suspicious breast lesions. Unlike traditional methods like mammography or ultrasound, this approach uses Molecular Breast Imaging (MBI) with technetium Tc-99m sestamibi, a radioactive tracer that highlights areas of concern with greater precision. This can lead to more accurate biopsies, potentially catching cancers that might be missed by other techniques. By using this method, doctors might improve early detection and diagnosis, which is crucial for successful treatment.

What evidence suggests that molecular breast imaging is effective for guiding breast biopsies?

Research shows that molecular breast imaging (MBI) can more effectively detect breast cancer, particularly in women with dense breast tissue. Studies have found that MBI detects 7 to 8 more cancers per 1,000 women screened compared to traditional mammograms, which find only 2 to 3 extra cancers. One study found that MBI correctly identifies breast cancer in 91% of cases. Additionally, MBI results in fewer false alarms, reducing unnecessary follow-up tests. In this trial, participants in one arm will receive technetium Tc-99m sestamibi and undergo MBI, while those in another arm will also undergo a biopsy if lesions are visualized. These findings suggest that MBI could be a helpful tool for guiding breast biopsies when other imaging methods are insufficient. ^{2 6 7 8 9}

Who Is on the Research Team?

Katie N. Hunt, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who have had a benign breast abnormality detected by MBI in the past 3 years. They must not be pregnant, breastfeeding within the last 2 months, or have had recent breast surgery. Participants need a negative pregnancy test before biopsy if they can become pregnant and must consent to join.

Inclusion Criteria

You had a breast imaging test in the last 3 years that found something in your breast, but it turned out not to be harmful after more tests or check-ups.

I need a biopsy for a breast abnormality found on an imaging test.

You had a breast imaging test in the past 3 years that found something in your breast, but further tests showed it was not cancer.

Exclusion Criteria

I had breast surgery within the last year.

I am under 18 years old.

I have a breast implant in the breast with the cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part I: MBI Imaging

Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study

1 day

1 visit (in-person)

Part II: MBI Imaging and Biopsy

Patients receive technetium Tc-99m sestamibi IV and undergo MBI. If lesions are visualized, a biopsy is performed using the Stereo Navigator accessory

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the biopsy procedure

3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Molecular Breast Imaging

Trial Overview The study evaluates high-resolution molecular breast imaging (MBI) as a guide for biopsy in patients with breast abnormalities. It aims to see if MBI is more accurate than ultrasound or mammography when these methods don't show clear images of lesions.

How Is the Trial Designed?

Group I: Part II (technetium Tc-99m sestamibi, MBI, biopsy) Experimental Treatment 4 Interventions

Patients receive technetium Tc-99m sestamibi IV and undergo MBI. Patients whose breast lesions of interest are visualized on MBI then undergo breast biopsy using the Stereo Navigator accessory.

Group II: Part I (technetium Tc-99m sestamibi, MBI) Experimental Treatment 2 Interventions

Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study.

Molecular Breast Imaging is already approved in United States, European Union for the following indications:

Approved in United States as Molecular Breast Imaging for:

• Breast cancer screening
• Breast biopsy guidance
• Assessment of breast cancer treatment response

Approved in European Union as Molecular Breast Imaging for:

• Supplemental breast cancer screening in dense breast tissue
• Investigation of breast abnormalities

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Molecular breast imaging (MBI) is an effective nuclear medicine technique for detecting breast lesions that may be cancerous, with advancements allowing for tissue sampling from these lesions using specialized camera systems.

The article provides guidance on integrating MBI and MBI-guided biopsy into breast imaging workflows, emphasizing the importance of selecting appropriate biopsy equipment and ensuring radiation safety during the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Breast Imaging-guided Percutaneous Biopsy of Breast Lesions: A New Frontier on Breast Intervention. Adrada, BE., Moseley, T., Kappadath, SC., et al.[2021]

The study evaluated a new molecular breast imaging (MBI) device for 99mTc-sestamibi-guided biopsy in 38 women, successfully localizing and sampling breast lesions, with all procedures technically successful and adequate for histopathological analysis.

The method identified 50% of the lesions as malignant, demonstrating its efficacy in diagnosing breast lesions, while the procedure had a mean time of 71 minutes and a low incidence of complications, including two hematomas and three vasovagal reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Clinical Experience Using Stereotactic Breast Biopsy Guided by 99mTc-Sestamibi. Collarino, A., Olmos, RAV., Neijenhuis, PA., et al.[2017]

Molecular breast imaging (MBI) is an effective and cost-efficient method for detecting breast cancers that may be hidden in dense breast tissue, which is often a limitation of traditional mammography.

Recent studies suggest that the uptake levels of the imaging agent in benign dense tissue could provide valuable information regarding breast cancer risk, highlighting the potential for MBI to not only detect cancer but also assess risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates in Molecular Breast Imaging. Hruska, CB.[2023]

The study developed a novel conical slant-hole (CSH) collimator for molecular breast imaging (MBI) that significantly improves lesion detection, achieving over 21 times the sensitivity compared to traditional parallel-hole collimators.

Using Monte Carlo simulations, the CSH collimator demonstrated the ability to accurately estimate the depth of breast lesions within 1.1 ± 0.7 mm error in just 1 minute, indicating its potential for rapid and precise biopsy guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collimator design for a dedicated molecular breast imaging-guided biopsy system: proof-of-concept. Weinmann, AL., Hruska, CB., Conners, AL., et al.[2021]

Molecular breast imaging (MBI) is effective in detecting more cancers than conventional imaging methods, especially in women with dense breast tissue or those at higher risk for breast cancer.

The radiation risk associated with MBI is minimal and comparable to that of mammography, making it a safe and cost-effective option that can be easily integrated into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Breast Imaging in Clinical Practice. Dibble, EH., Hunt, KN., Ehman, EC., et al.[2020]

Molecular breast imaging (MBI) demonstrated a high cancer detection rate of 15.4 per 1000 exams, with 63.6% of detected malignancies not visible on concurrent mammograms, highlighting its effectiveness as a supplemental screening tool.

The study found that while MBI effectively identified mass uptake, it had lower success in detecting nonmass uptake, leading to a higher reliance on MRI for further evaluation, indicating a need for more research to optimize screening practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Downstream imaging following abnormal molecular breast imaging, lessons learned and suggestions for success. Maimone, S., Hatcher, KM., Tavana, A., et al.[2022]

Molecular breast imaging (MBI) with 99mTc-sestamibi has improved significantly, offering lower doses and higher resolution, making it a valuable tool for breast cancer screening, especially in women with dense breast tissue.

MBI is not only effective for supplemental screening but also useful for assessing treatment responses, evaluating the extent of disease, and predicting breast cancer risk, highlighting its versatility in breast cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances and Future Directions in Molecular Breast Imaging. Covington, MF., Parent, EE., Dibble, EH., et al.[2022]

Molecular breast imaging (MBI) detects additional hidden breast cancers in 9% of women with newly diagnosed breast cancer and has a high sensitivity of 98% for invasive cancers and 91% for ductal carcinoma in situ.

MBI is increasingly used for monitoring treatment response in women undergoing chemotherapy and can influence surgical decisions in nearly 25% of newly diagnosed breast cancer patients, highlighting its importance in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Breast Imaging: A Comprehensive Review. Huppe, AI., Mehta, AK., Brem, RF.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4303579/

Molecular breast imaging: an emerging modality for ... A recent screening trial in women with dense breast tissue yielded a cancer detection rate of 3.2 per 1000 for mammography alone and 12.0 per 1000 for the ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/63/1/17

Advances and Future Directions in Molecular Breast Imaging MBI also provides favorable false-positive rates (20), favorable recall rates (8), rapid interpretation times (18), low cost (15), few ...

3. rsna.org rsna.org/news/2025/september/molecular-breast-imaging

Molecular Breast Imaging May Benefit Women with Dense ... “MBI detected an additional 6.7 cancers per 1,000 screenings at Year 1 and an additional 3.5 cancers per 1,000 screenings at Year 2,” Dr. Hruska ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2603338/

Molecular Breast Imaging: A review of the Mayo Clinic ... Using a single head system, sensitivity for breast cancer detection was 85% (57/67) overall and 29% for tumors ≤5mm in diameter. Sensitivity improved to 91% ( ...

5. densebreast-info.org densebreast-info.org/screening-technologies/molecular-breast-imaging/

Molecular Breast Imaging | DenseBreast-info, Inc ... MBI, performed with a low-radiation-dose protocol, detects an additional 7 to 8 cancers per thousand women screened compared to 2D mammography ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8717200/

Advances and Future Directions in Molecular Breast Imaging MBI excels with high lesion-to-background contrast in individuals with dense breasts or breast implants (18), with an incremental cancer detection rate of 8.8 ...

7. mayoclinic.org mayoclinic.org/tests-procedures/molecular-breast-imaging/about/pac-20394710

Molecular breast imaging Molecular breast imaging is a test to look for signs of breast cancer. It uses a radioactive tracer and a special camera to make pictures of the breast tissue.

8. nature.com nature.com/articles/s41416-024-02930-1

Women's perspectives of molecular breast imaging The whole-body effective dose of MBI is higher than that of mammography, with an associated increased risk of radiation-induced cancer. The ...

9. mayoclinichealthsystem.org mayoclinichealthsystem.org/hometown-health/speaking-of-health/closer-look-at-molecular-breast-imaging

Molecular breast imaging FAQ Studies show that combining molecular breast imaging and a mammogram leads to finding three times more breast cancers than a mammogram alone.