18F-TFB PET Imaging for Thyroid Cancer

Overseen By Alan L Ho, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Amiodarone

Disqualifiers: Pregnancy, Lactation, Active infection, others

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

Compensation: Varies

Number of Visits: 3

5 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new scan that can quickly show how much radioactive iodine thyroid cancer will absorb. It aims to help doctors plan treatment more effectively without interfering with the therapy. The study focuses on patients with thyroid cancer to improve their treatment outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you require medication with high iodine content, like amiodarone. If you have had iodinated contrast for imaging recently, you may need to ensure excess iodine is cleared from your system.

What data supports the effectiveness of the drug 18F-TFB for thyroid cancer?

Research shows that 18F-TFB is effective in imaging thyroid cancer by targeting the sodium/iodide symporter, which is important for detecting cancer cells. It provides high-quality images with lower radiation compared to traditional iodine-based methods, making it a promising tool for diagnosing thyroid cancer. ^{1 2 3 4 5}

Is 18F-TFB PET imaging safe for humans?

Research shows that 18F-TFB PET imaging is generally safe for humans, with no adverse effects observed in studies involving both healthy individuals and thyroid cancer patients. The radiation exposure from 18F-TFB is similar to other commonly used imaging agents, and it is considered safe for use in humans. ^{1 2 3 5 6}

How does the drug 18F-TFB differ from other treatments for thyroid cancer?

18F-TFB is unique because it is a PET imaging agent that targets the sodium/iodide symporter (NIS) in thyroid cancer cells, providing high-quality images with lower radiation exposure compared to traditional iodine-based imaging methods. Unlike radioiodides, 18F-TFB does not undergo organification in thyroid cells, which reduces uptake in normal thyroid tissue and enhances imaging specificity. ^{1 2 3 5 6}

Research Team

Ravinder Grewal, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with thyroid cancer of follicular origin, who can sign consent and follow a low iodine diet. They must have normal organ function, not be pregnant or breastfeeding, use contraception if fertile, and have tumors visible on imaging tests. Exclusion includes uncontrolled illness, recent iodinated contrast exposure without clearance, and non-compliance.

Inclusion Criteria

I am not pregnant or cannot become pregnant.

My organs and bone marrow are functioning normally.

I am 18 years old or older.

Exclusion Criteria

I had a CT scan with dye within the last 3 months but my body has cleared the iodine.

Pregnant, lactating, or breast feeding women

Unwillingness or inability to comply with study procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants receive a single dose of 18F-TFB followed by dynamic PET/CT scans

1 day

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

2 days

Treatment Details

Interventions

• 18F-tetrafluoroborate (18F-TFB)

Trial Overview The study tests a new PET imaging technique using 18F-Tetrafluoroborate (18F-TFB) to predict radioactive iodine uptake in thyroid cancer more quickly than current methods without affecting therapeutic radioactive iodine uptake.

Participant Groups

Group I: PET Imaging With 18F-TFB Experimental Treatment 2 Interventions

The intervention is the administration of a single dose of approximately 5-10 mCi 18F-TFB (mass \<= 50 μg) for imaging purposes. This will be followed by a 30 minute dynamic PET/CT study immediately after injection, at 60 minutes (+/- 10 min) and 4 hours (+/- 15 min) post injection. The second and third scan will last up to 30 minutes.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

References

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

Initial Clinical Investigation of [18F]Tetrafluoroborate PET/CT in Comparison to [124I]Iodine PET/CT for Imaging Thyroid Cancer. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics, metabolism and radiation dosimetry of 18F-tetrafluoroborate (18F-TFB) in healthy human subjects. [2020]

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

18F-Tetrafluoroborate, a PET Probe for Imaging Sodium/Iodide Symporter Expression: Whole-Body Biodistribution, Safety, and Radiation Dosimetry in Thyroid Cancer Patients. [2023]

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

Molecular imaging of advanced thyroid cancer: iodinated radiotracers and beyond. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Incremental diagnostic value of [18F]tetrafluoroborate PET-CT compared to [131I]iodine scintigraphy in recurrent differentiated thyroid cancer. [2021]

6. Australia pubmed.ncbi.nlm.nih.gov

[18F]Tetrafluoroborate ([18F]TFB) and its analogs for PET imaging of the sodium/iodide symporter. [2019]