Molecular Breast Imaging for Breast Cancer

Overseen By Gaiane M. Rauch, MD, PHD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Under 18, Pregnant, Nursing, 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: 5

96 Participants Needed

Trial Summary

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

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Tc99m sestamibi for breast cancer?

Research shows that Tc99m sestamibi is useful in detecting and diagnosing breast cancer, as it helps create detailed images of the breast. This imaging can assist doctors in managing breast cancer by providing additional information to guide treatment decisions. ^{1 2 3 4 5}

Is Tc-99m sestamibi safe for use in humans?

Tc-99m sestamibi has been used in various imaging studies, including for breast cancer and heart conditions. It is generally considered safe, but mild allergic reactions have been reported in some cases. ^{1 3 6 7 8}

How is molecular breast imaging different from other breast cancer treatments?

Molecular breast imaging (MBI) is unique because it uses a special tracer called Tc-99m sestamibi to create detailed images of the breast, which can help in detecting cancer, especially in women with dense breast tissue. Unlike traditional imaging methods, MBI can also assess how well a patient is responding to chemotherapy and evaluate the risk of breast cancer. ^{1 3 9 10 11}

What is the purpose of this trial?

This clinical trial studies technetium Tc-99m sestamibi molecular breast imaging in predicting tumor response in patients with locoregional breast cancer that has spread from where it began in the breast to surrounding normal tissue who are receiving neoadjuvant chemotherapy. Comparing results of diagnostic procedures, such as technetium Tc-99m sestamibi molecular breast imaging, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Research Team

Gaiane M. Rauch

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women over 18 with newly diagnosed invasive breast cancer that hasn't spread beyond the local area and who are scheduled for chemotherapy. They must not be pregnant, nursing, or allergic to Tc99m sestamibi.

Inclusion Criteria

My breast cancer is at stage T1-T4, may have spread to nearby lymph nodes but not to distant parts of the body.

I am a woman aged 18 or older.

Patients who agree to sign an informed consent to undergo MBI

Exclusion Criteria

You are allergic to Tc99m sestamibi.

My cancer has spread to my chest wall.

Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Imaging

Participants undergo technetium Tc-99m sestamibi molecular breast imaging before the start of neoadjuvant chemotherapy

1 week

1 visit (in-person)

Neoadjuvant Chemotherapy

Participants receive neoadjuvant chemotherapy and undergo imaging after 2 cycles and at completion of chemotherapy

6-12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Tc99m sestamibi

Trial Overview The study tests if a special imaging technique using technetium Tc-99m sestamibi can predict how well patients respond to pre-surgery chemotherapy in treating locoregional breast cancer.

Participant Groups

Group I: Molecular Breast Imaging (MBI) + Tc99m sestamibi Experimental Treatment 2 Interventions

Participants undergo 3 MBI scans with injections of injection of Tc99m sestamibi before each scan. First scan is 7 days before scheduled chemotherapy treatment, after 2 cycles of chemotherapy, and after completion of chemotherapy treatment.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of Tc-99 m sestamibi uptake quantification with few-projection emission tomography. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

The initial Australian experience of technetium-99M sestamibi scintimammography: a complementary test in the management of breast cancer. [2019]

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

Monte Carlo-derived 99m Tc uptake quantification with commercial planar MBI: Absolute tumor activity. [2023]

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

International prospective evaluation of scintimammography with technetium-99m sestamibi: interim results. [2019]

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

Mammoscintigraphy with technetium-99m-sestamibi in suspected breast cancer. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

Comparison of Tc-99m maraciclatide and Tc-99m sestamibi molecular breast imaging in patients with suspected breast cancer. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Exanthema after a stress Tc-99m sestamibi study: continue with a rest sestamibi study? [2016]

8. England pubmed.ncbi.nlm.nih.gov

Prediction of mortality in patients with coronary artery disease undergoing vasodilator stress testing: a comparison between 99mTc-tetrofosmin and 99mTc-sestamibi. [2016]

9. Ireland pubmed.ncbi.nlm.nih.gov

Scintigraphic imaging of breast tumors. [2019]

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

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

11. Italy pubmed.ncbi.nlm.nih.gov

Methodological aspects of 99mTc-sestamibi guided biopsy in breast cancer. [2020]