RecruitingObservational

Evaluation of F-18 Tetrafluoroborate (18F-TFB) PET/CT in Patients With Differentiated Thyroid Cancer

NCT ID: NCT05575440Sponsor: Mayo ClinicLast updated: 2026-02-27

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.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate fluorine F 18 tetrafluoroborate (18F-TFB) positron emission tomography (PET)/computed tomography (CT) imaging in patients with intermediate or high risk differentiated thyroid cancer (DTC) and compare to the current clinical standard. II. Assess the impact of 18F-TFB PET/CT on clinical management. OUTLINE: Patients receive fluorine F 18 tetrafluoroborate intravenously (IV) and undergo PET/CT scan on study.

Arms & interventions

ProcedureComputed Tomography
Undergo a PET/CT scan
RadiationFluorine F 18 Tetrafluoroborate
Given IV
ProcedurePositron Emission Tomography
Undergo a PET/CT scan
OtherSurvey Administration
Ancillary studies

Outcome measures

Primary

Descriptive summaries of detected lesions
Descriptive summaries of detected lesions (presence/absence) will include counts and proportions at the patient and lesion level. Overall concordance of these measures across modalities will be estimated using Cohen's kappa with 95% confidence intervals generated by clustered bootstrapping. Per-lesion analysis of detection rates by modality will be performed using cluster-adjusted McNemar's test, accounting for the paired nature of the data (i.e., two scans) and potential within-sample correlation for patients with multiple lesions.
Time frame: Up to 2 years
Conspicuities and diagnostic confidence scores for a given lesion
Conspicuities and diagnostic confidence scores for a given lesion will be averaged across readers. Descriptive summaries of these scores will include medians and interquartile ranges. Concordance of these measures across modality will be evaluated using Lin's concordance correlation coefficient with 95% confidence intervals generated by clustered bootstrapping. Differences in conspicuities and diagnostic confidence scores will be tested using cluster-adjusted Wilcoxon signed-rank tests.
Time frame: Up to 2 years

Secondary

True positive and negative lesions
Time frame: Up to 2 years
Impact of PET on clinical management in differentiated thyroid cancer (DTC) patients
Time frame: Up to 2 years
Inter-reader reproducibility
Time frame: Up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting

Clinical Trials Referral Office · Contact

855-776-0015 mayocliniccancerstudies@mayo.edu

Stephen M. Broski, M.D. · Principal Investigator