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NCT Number: NCT05575440

Evaluation of 18F-TFB PET/CT Scan in Patients With Differentiated Thyroid Cancer

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.

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Key information

Conditions

Differentiated Thyroid Gland Carcinoma Adenocarcinoma Adenocarcinoma, Follicular Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Gland Follicular Carcinoma Thyroid Gland Papillary Carcinoma Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Stephen M. Broski, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Procedure

Undergo a PET/CT scan

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Fluorine F 18 Tetrafluoroborate

Radiation

Given IV

Other names: 18F-Tetrafluoroborate, 18F-TFB

Positron Emission Tomography

Procedure

Undergo a PET/CT scan

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Descriptive summaries of detected lesions

    Time frame: Up to 2 years

    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.

  2. Conspicuities and diagnostic confidence scores for a given lesion

    Time frame: Up to 2 years

    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.

Secondary outcomes

  1. True positive and negative lesions

    Time frame: Up to 2 years

    Given true positive and negative lesions determined by histopathology and/or imaging, clinical and laboratory follow-up, we will estimate sensitivity, specificity, net present value, and positive predictive value on a per-lesion and patient basis for 18F TFB PET/CT and 123I single-photon emission computerized tomography/CT along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using clustered bootstrapping.

  2. Impact of PET on clinical management in differentiated thyroid cancer (DTC) patients

    Time frame: Up to 2 years

    The impact of PET on clinical management in DTC patients will be evaluated using descriptive statistics. Evidence of discordance among the modalities will be assessed using a McNemar- Bowker test of symmetry.

  3. Inter-reader reproducibility

    Time frame: Up to 2 years

    Inter-reader reproducibility will be assessed for positivity at the patient level and region level (nominal) as well as standardized uptake values (SUVs) for positive lesions (quantitative). Reproducibility will be reported using the Fleiss' Kappa test for multiple readers for positivity and Pearson intra-class correlation for SUVs.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Oct 12, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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