Recruiting

18F-TFB

Sponsor:

Mayo Clinic

Code:

NCT05575440

Conditions

Differentiated Thyroid Gland Carcinoma

Thyroid Gland Follicular Carcinoma

Thyroid Gland Papillary Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Fluorine F 18 Tetrafluoroborate

Positron Emission Tomography

Survey Administration

Study Details

Brief summary:

This phase II study evaluates F-18 tetrafluoroborate (18F-TFB) PET/CT scan in patients with differentiated thyroid cancer. Diagnostic imaging is necessary for planning treatment, monitoring therapy response, and identifying sites of recurrent or metastatic disease in differentiated thyroid cancer. 18F-TFB PET/CT may accurately detect recurrent and metastatic thyroid cancer lesions, with the potential to provide information for patient management that is better than the current standard of care imaging practices.

Conditions

Differentiated Thyroid Gland Carcinoma

Thyroid Gland Follicular Carcinoma

Thyroid Gland Papillary Carcinoma

Study ID

NCT05575440

Start date

Apr 22, 2022

Status verified date

Jul, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject has biopsy-proven papillary or follicular thyroid cancer
  • Subject is clinically indicated for 123I-SPECT/CT total body iodine (TBI) scan
  • Subject agrees to undergo 18F-TFB PET/CT scan following TBI scan
  • Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent)
  • Subject is able to be scanned - able to lie still on SPECT/CT and PET/CT scanner table for up to 65 minutes (min)
  • Age 18 or older
  • Ability to understand a written informed consent document, and the willingness to sign it
  • Subject is not pregnant

Exclusion Criteria:

  • Contrast-enhanced CT within 4 last weeks
  • Amiodarone within last 4 months
  • Ingested iodine, kelp tablets, Lugols iodine, or potassium iodide (SSKI) within 2 weeks
  • Unable to lie flat, still or tolerate a PET scan
  • Applied betadine, iodoform, or quick tanning products to skin within last two weeks
  • If using medication withdrawal for stimulation, then exclude if thyroid stimulating hormone (TSH) level < 25
  • Taken anti-thyroid medication within 1 week
  • Subject is breastfeeding
  • Positive pregnancy test

Study Design

Enrollment

24 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (18F-TFB PET/CT)

Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study.

Interventions

Computed Tomography

Undergo a PET/CT scan

Fluorine F 18 Tetrafluoroborate

Given IV

Positron Emission Tomography

Undergo a PET/CT scan

Survey Administration

Ancillary studies

Primary outcome measure

  • Descriptive summaries of detected lesions [ Time Frame: Up to 2 years ]
  • Conspicuities and diagnostic confidence scores for a given lesion [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Stephen M. Broski, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-29.