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

Trial Summary

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 data supports the effectiveness of the treatment Molecular Breast Imaging (MBI) for breast cancer?

Molecular Breast Imaging (MBI) is effective in detecting additional hidden breast cancers in 9% of women with newly diagnosed breast cancer and has a high sensitivity for detecting high-risk lesions, identifying 98% of invasive breast cancer and 91% of ductal carcinoma in situ. It is also useful for women with dense breasts, detecting hidden cancer in up to 16.5 per 1000 women, and influences surgical management in nearly a quarter of women with newly diagnosed breast cancer. ^{1 2 3 4 5}

Is Molecular Breast Imaging (MBI) safe for humans?

Molecular Breast Imaging (MBI) is considered safe for humans, with minimal radiation risk similar to that of mammography. It is well tolerated and has been integrated into clinical practice for over a decade. ^{1 2 3 5 6}

How is the treatment Molecular Breast Imaging (MBI) different from other breast cancer treatments?

Molecular Breast Imaging (MBI) is unique because it uses a special type of camera to detect breast cancer based on how the tissue functions, rather than just its structure, which is how traditional mammograms and ultrasounds work. This allows MBI to find cancers that might be hidden in dense breast tissue and can guide biopsies of suspicious areas that other methods might miss. ^{1 2 3 7 8}

What is the purpose of this trial?

This clinical trial tests how well molecular breast imaging (MBI) works to guide the collection of a breast biopsy in patients with a breast abnormality. Currently, a biopsy is often guided by either ultrasound or mammography in order to ensure that a sample of the correct part of the breast is taken. Sometimes a lesion or part of the lesion cannot be seen on ultrasound or mammography, and, therefore, a biopsy guided with ultrasound or mammography may not be always be accurate. Studies have shown that high resolution MBI may have potential to improve the detection of some breast tumors. This trial uses a new high-resolution MBI system that may help perform a biopsy using MBI.

Research Team

Katie N. Hunt, M.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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) 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]

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]

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]

References

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

Molecular Breast Imaging: A Comprehensive Review. [2018]

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

Molecular Breast Imaging-guided Percutaneous Biopsy of Breast Lesions: A New Frontier on Breast Intervention. [2021]

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

Updates in Molecular Breast Imaging. [2023]

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

Advances and Future Directions in Molecular Breast Imaging. [2022]

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

Downstream imaging following abnormal molecular breast imaging, lessons learned and suggestions for success. [2022]

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

Molecular Breast Imaging in Clinical Practice. [2020]

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

Collimator design for a dedicated molecular breast imaging-guided biopsy system: proof-of-concept. [2021]

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

First Clinical Experience Using Stereotactic Breast Biopsy Guided by 99mTc-Sestamibi. [2017]