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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special imaging technique called technetium Tc-99m sestamibi molecular breast imaging. The goal is to assess how well this method predicts breast cancer tumors' response to chemotherapy. Women with breast cancer that has spread to nearby tissues and who are scheduled for chemotherapy might be suitable candidates. Participants will undergo scans before, during, and after chemotherapy to assist doctors in planning the best treatment strategy. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future breast cancer treatment strategies.

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 prior data suggests that technetium Tc-99m sestamibi molecular breast imaging is safe for predicting tumor response?

Research has shown that technetium Tc-99m sestamibi has been tested for safety in molecular breast imaging. This imaging uses a small amount of radiation, comparable to the annual natural environmental exposure. The radiation dose to the breast from this procedure is lower than that from standard mammograms. Studies have found that patients tolerate this level of radiation well, with no significant reports of severe side effects from using Tc-99m sestamibi. Overall, this imaging method appears safe for detecting breast cancer and predicting treatment response. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional breast cancer imaging methods like mammograms and MRIs, Molecular Breast Imaging (MBI) with Tc99m sestamibi offers a unique approach. This technique uses a radioactive tracer, Tc99m sestamibi, which highlights cancerous tissues more clearly by targeting areas with high metabolic activity, potentially leading to earlier and more accurate detection. Researchers are excited because MBI can provide clearer images in dense breast tissue, where standard imaging might miss tumors. This method could enhance the precision of breast cancer treatment plans, making it a promising tool in the fight against this disease.

What evidence suggests that technetium Tc-99m sestamibi molecular breast imaging is effective for predicting tumor response in locoregional breast cancer?

Research has shown that Tc99m sestamibi with Molecular Breast Imaging (MBI), which participants in this trial will receive, can help detect breast cancers by highlighting areas with increased blood flow and cell activity. This imaging method can also predict a tumor's response to chemotherapy. Studies indicate that MBI detects more cancers than traditional methods like mammograms and effectively notices changes in the breast during treatment. Although it uses some radiation, the amount is less than that of a standard mammogram, making it a promising tool for planning breast cancer treatment. ^{2 5 6 7 8}

Who Is on the Research Team?

Gaiane M. Rauch

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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/PMC8717200/

Advances and Future Directions in Molecular Breast Imaging The average absorbed radiation dose to the breast from 300 MBq (8 mCi) of 99mTc-sestamibi is estimated to be 1.1 mGy, compared with 3.0–4.5 mGy with mammography ...

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/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 ...

4. ajronline.org ajronline.org/doi/abs/10.2214/AJR.15.15924

Supplemental Breast Cancer Screening With Molecular Breast ... The incremental cancer detection rate was 7.7‰ (95% CI, 4.5–13.1‰), the recall rate was 8.4% (95% CI, 7.2–9.8%), and the biopsy rate was 3.7% (95% CI, 2.9%–4.7 ...

5. 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 ...

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

Technetium 99m Sestamibi - StatPearls - NCBI Bookshelf - NIH The standard dosing used in molecular breast imaging is approximately 300 megabecquerel of sestamibi using dual-head cadmium zinc telluride cameras. In this ...

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

Advances and Future Directions in Molecular Breast Imaging The average absorbed radiation dose to the breast from 300 MBq (8 mCi) of 99mTc-sestamibi is estimated to be 1.1 mGy, compared with 3.0–4.5 mGy ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9077005/

Updates in Molecular Breast Imaging - PMC The current effective radiation dose of MBI using 8 mCi Tc-99m sestamibi (2.1 mSv) is below annual background radiation levels (average 3 mSv; range 2 to 10 mSv) ...