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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of Molecular Breast Imaging (MBI), which uses a small amount of a radioactive substance called Tc99m sestamibi, compared to the standard breast MRI in detecting breast cancer. It focuses on women at high risk for breast cancer, such as those with certain genetic mutations or a history of specific breast conditions. The trial will assess how the test results vary based on the size, type, and location of any breast tumors. Women already scheduled for a breast MRI who can complete both tests within two weeks may find this trial suitable. Participants will also complete a survey about their experience with both tests. As an unphased trial, this study offers a unique opportunity to advance breast cancer detection methods.

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 prior data suggests that Tc99m sestamibi is safe for detecting breast cancer?

Research has shown that Tc99m sestamibi is a well-known tool for diagnosing health issues. The FDA has approved it for use when other imaging tests, like mammograms, are insufficient. This approval indicates its general safety for people. Studies have demonstrated that Tc99m sestamibi aids in detecting breast cancer by using a small amount of radioactive material to highlight areas in the breast.

The safety of this tracer is well-established. It is widely used in breast imaging, and most people tolerate it well. Serious side effects are rare. Some might experience mild reactions, such as feeling flushed or discomfort at the injection site, but these are uncommon. Overall, Tc99m sestamibi is considered safe for many patients when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for breast cancer detection, which typically involves MRI scans, the treatment being investigated uses Tc99m sestamibi in a technique known as Molecular Breast Imaging (MBI). This method is unique because it involves injecting a small amount of radioactive material that targets cancer cells, potentially offering clearer images of breast tissue. Researchers are excited about this approach because it might be more effective in detecting cancer in dense breast tissue, which is a limitation of traditional MRI. This could lead to earlier and more accurate diagnoses for patients with dense breasts.

What evidence suggests that MBI is effective for detecting breast cancer?

Research has shown that Tc99m sestamibi, which participants in this trial may receive, can effectively diagnose breast cancer, especially when mammogram results are unclear. Studies indicate that Tc99m sestamibi has a 92% success rate in correctly identifying those with breast cancer and a 95% success rate in correctly identifying those without it. This means it can accurately detect breast cancer in most cases. Additionally, Tc99m sestamibi can help reduce unnecessary biopsies, which involve removing tissue for testing. These findings suggest that Tc99m sestamibi is a promising option for detecting breast cancer in women at high risk. ^{3 6 7 8 9}

Who Is on the Research Team?

Beatriz Adrada

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3490387/

Accuracy of 99mTc-sestamibi scintimammography for breast ... In this study, 99m Tc-sestamibi scintimammography was shown to be an important tool for diagnosing breast cancer when mammography was inconclusive.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02324387

NCT02324387 | Tc99m Sestamibi Molecular Breast Imaging This clinical trial studies technetium Tc-99m sestamibi molecular breast imaging in predicting tumor response in patients with locoregional breast cancer.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960740402000300

A review of the cost-effectiveness of Tc-99m sestamibi ... The analysis data indicate that Tc-99m sestamibi scintimammography can save the cost of unnecessary biopsies in Taiwanese women with non-diagnostic mammogram ...

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

Molecular breast imaging: an emerging modality for ... Administered doses of approximately 150 MBq Tc-99m sestamibi result in a breast dose of 0.25 mGy and an effective dose of approximately 1.1 mSv to the body. At ...

5. ajronline.org ajronline.org/doi/10.2214/ajr.174.6.1741779

Comparative Value of 99m Tc-Sestamibi Scintimammography ... RESULTS. Sensitivity and specificity in detecting breast cancer were 92% and 95%, respectively, for scintimammography and 100% and 48%, respectively, for ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553148/

Technetium 99m Sestamibi - StatPearls - NCBI Bookshelf - NIH Sestamibi is part of the radioactive diagnostic agents class of medications, characterized as a lipophilic cationic radiotracer.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/019785s022lbl.pdf

Sestamibi - accessdata.fda.gov Breast Imaging: MIRALUMA®, Kit for the Preparation of Technetium Tc99m Sestamibi for. Injection, is indicated for planar imaging as a second line diagnostic ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0037198X2100078X

Updates in Molecular Breast Imaging Tc-99m sestamibi uptake on MBI, which reflects blood flow and mitotic activity of breast tissues, is known to detect breast cancers and more recently found to ...

9. journals.lww.com journals.lww.com/nuclearmed/fulltext/2025/07000/can_molecular_breast_imaging_with_tc_99m_sestamibi.2.aspx

Can Molecular Breast Imaging With Tc-99m Sestamibi ... Tc-99m sestamibi is Food and Drug Administration (FDA)–approved as a second-line diagnostic tracer after mammography to study breast lesions and European ...