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.
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)
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
Subjects have biopsy-proven papillary or follicular thyroid cancer and is clinically indicated for 123I-single-photon emission computerized tomography (I-SPECT)/CT total body iodine (TBI) scan
Cohort
Prospective
Computed Tomography
Procedure/SurgeryUndergo a PET/CT scan
Fluorine F 18 Tetrafluoroborate
RadiationGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo a PET/CT scan
Survey Administration
Other interventionAncillary studies
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.
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.
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.
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.
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.
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