MBI vs. MRI for Detecting Breast Cancer

Overseen By Beatriz Adrada

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy

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

Compensation: Varies

Number of Visits: 2

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

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

Research shows that Tc99m sestamibi is effective in molecular breast imaging (MBI) for detecting breast cancer, especially in women with dense breast tissue. It helps in assessing the response to chemotherapy and can be used alongside mammography to improve diagnostic accuracy. ^{1 2 3 4 5}

Is Tc99m sestamibi safe for use in humans?

Tc99m sestamibi, used in molecular breast imaging (MBI), has been studied for its safety in humans. It is commonly used in breast cancer detection and has been shown to be a feasible and safe technique for imaging and guiding surgery. ^{2 4 5 6 7}

How does the drug Tc99m sestamibi differ from other breast cancer detection methods?

Tc99m sestamibi is used in molecular breast imaging (MBI) to create functional images of the breast, which can be particularly useful for women with dense breast tissue. Unlike MRI, which can have high costs and false positives, MBI with Tc99m sestamibi offers a lower-dose, higher-resolution alternative that can also assess treatment response and predict breast cancer risk. ^{2 4 5 8 9}

What is the purpose of this trial?

To evaluate the diagnostic performance of Tc99m sestamibi (MBI) compared to breast MRI in women who are at high risk for developing breast cancer. To assess the relationship of tumor size, histologic subtype and location of lesion and how it affects lesion conspicuity and sensitivity in MBI detected cancers.

Research Team

Beatriz Adrada

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women aged 18 or older at high risk for breast cancer, which includes those with a lifetime risk over 20%, certain cell changes like lobular neoplasia or atypical ductal hyperplasia, or known genetic mutations. Pregnant women can't participate due to the use of radioactive tracers and gadolinium.

Inclusion Criteria

I am at high risk for breast cancer due to my genetics or specific breast changes.

I agree to undergo breast imaging and biopsy if needed, and to complete a survey about my experience.

I am a woman over 18 at high risk for breast cancer referred to MDACC.

Exclusion Criteria

I am not pregnant, as the required tests are unsafe during pregnancy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo Molecular Breast Imaging (MBI) and Magnetic Resonance Imaging (MRI) to evaluate diagnostic performance

1-2 weeks

1 visit (in-person)

Follow-up

Participants complete a post-examination survey and follow-up questionnaire to assess patient preference and gather additional data

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• Tc99m sestamibi

Trial Overview The study is comparing two imaging techniques: Molecular Breast Imaging (MBI) using Tc99m sestamibi and Magnetic Resonance Imaging (MRI). It aims to see how well MBI performs in detecting breast cancer compared to MRI, especially considering tumor size, type, and location.

Participant Groups

Group I: Tc99m sestamibi Experimental Treatment 1 Intervention

MBI uses an injection of a small amount of radioactive material called technetium99m (Tc99m) sestamibi

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

Diagnostic accuracy of 99mTc-sestamibi breast imaging: multicenter trial results. [2016]

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

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

3. England pubmed.ncbi.nlm.nih.gov

The role of Tc99m-sestamibi scintimammography in combination with the triple assessment of primary breast cancer. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

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

Radioguided surgery using intravenous 99mTc sestamibi associated with breast magnetic resonance imaging for guidance of breast cancer resection. [2022]

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

Diagnostic Performance of MRI, Molecular Breast Imaging, and Contrast-enhanced Mammography in Women with Newly Diagnosed Breast Cancer. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of mammographic breast lesions with Tc-99m sestamibi scintimammography and contrast enhanced MRI. [2015]