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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging test using 18F-tetrafluoroborate (18F-TFB) to determine if it can predict thyroid cancer's absorption of radioactive iodine, used in treatment. The goal is to deliver results faster than current methods without compromising treatment effectiveness. Individuals with confirmed thyroid cancer visible on scans such as PET, ultrasound, CT, or MRI may be suitable candidates.

As an unphased trial, this study presents a unique opportunity to contribute to innovative research that could enhance future thyroid cancer treatments.

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 prior data suggests that this imaging test is safe for thyroid cancer patients?

Research has shown that 18F-tetrafluoroborate (18F-TFB) is safe for humans. Studies have found it can be used safely, and it spreads in the body in a way that makes it useful for checking thyroid problems. This treatment acts like a marker, highlighting certain areas during scans. Although more research is needed, current findings suggest that 18F-TFB does not cause major side effects, making it a promising option for imaging thyroid cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-tetrafluoroborate (18F-TFB) PET imaging for thyroid cancer because it offers a new way to visualize the cancer that differs from current methods like ultrasound or radioactive iodine scans. Unlike these traditional imaging techniques, 18F-TFB PET imaging uses a special compound that can provide clearer, more detailed images of thyroid cancer cells in the body. This approach can help doctors pinpoint the exact location and extent of the cancer more accurately and potentially faster, improving treatment planning and outcomes.

What evidence suggests that this imaging test is effective for thyroid cancer?

Research has shown that 18F-tetrafluoroborate (18F-TFB), the investigational agent used in this trial, is a promising tool for detecting thyroid cancer. Studies have found that it identifies cancer that has returned or spread more accurately than some current methods. One study discovered that 18F-TFB PET/CT scans are better at detecting cancer that has spread to lymph nodes before surgery. Another study indicated that this method exposes patients to less radiation compared to traditional scans. Overall, early findings suggest that 18F-TFB can help manage thyroid cancer by predicting how well the cancer will respond to treatment. ^{2 4 5 6 7}

Who Is on the Research Team?

Ravinder Grewal, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 will use birth control during and for 6 months after treatment, as my doctor advises.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12520085/

[18F]Tetrafluoroborate PET/CT for detecting differentiated ... This study aims to demonstrate that [18F]TFB PET/CT will improve the detection of pre-operative lymph node metastases and enhance the prediction ...

2. etj.bioscientifica.com etj.bioscientifica.com/view/journals/etj/14/1/ETJ-24-0320.xml

[18F]Tetrafluoroborate, a new NIS PET/CT radiopharmaceutical TFB is a promising tracer in relapsing DTC, showing higher sensitivity and less radiation exposure than the standard methods.

3. jnm.snmjournals.org jnm.snmjournals.org/content/65/2/192

Diagnostic Performance of [ 18 F]TFB PET/CT Compared with ... The aim of this study was to compare [ 18 F]TFB PET with high-activity posttherapeutic [ 131 I]iodine whole-body scintigraphy and SPECT/CT in recurrent DTC.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03196518

Study of PET Imaging With 18F-TFB in Patients ... The goal of the study is to evaluate a new imaging test that may allows the investigators to predict the uptake of radioactive iodine by thyroid cancer faster ...

5. trialx.com trialx.com/clinical-trials/listings/262048/evaluation-of-18f-tfb-petct-scan-in-patients-with-differentiated-thyroid-cancer/?&radius=50

Evaluation of 18F-TFB PET/CT Scan in Patients With ... 18F-TFB PET/CT may accurately detect recurrent and metastatic thyroid cancer lesions, with the potential to provide information for patient ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6205602/

18F--tetrafluoroborate (18F--TFB), a PET probe for imaging ... It is safe to administer in humans and its biodistribution and dosimetry warrant further clinical evaluation as a PET tracer for imaging thyroid pathophysiology ...

7. ejnmmires.springeropen.com ejnmmires.springeropen.com/articles/10.1186/s13550-017-0337-5

Safety, pharmacokinetics, metabolism and radiation dosimetry ... 18 F-TFB is a promising iodide analog for PET imaging of thyroid cancer and sodium/iodide symporter (NIS) reporter activity in viral therapy applications.