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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Differentiated Thyroid Gland Carcinoma, Thyroid Gland Follicular Carcinoma, Thyroid Gland Papillary Carcinoma

Intervention / Treatment
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* Procedure: Computed Tomography
* Radiation: Fluorine F 18 Tetrafluoroborate
* Procedure: Positron Emission Tomography
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (18F-TFB PET/CT)<br>Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study. | Procedure: Computed Tomography<br>* Undergo a PET/CT scan<br>* Other names: tomography;Radiation: Fluorine F 18 Tetrafluoroborate<br>* Given IV<br>* Other names: 18F-TFB;Procedure: Positron Emission Tomography<br>* Undergo a PET/CT scan<br>* Other names: proton magnetic resonance spectroscopic imaging;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True positive and negative lesions | 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. | Up to 2 years | 
| Impact of PET on clinical management in differentiated thyroid cancer (DTC) patients | 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. | Up to 2 years | 
| Inter-reader reproducibility | 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. | Up to 2 years |