F-18 Tetrafluoroborate PET/CT in Differentiated Thyroid Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara University
About this trial
In patients who have undergone surgery for differentiated thyroid cancer and who demonstrate elevated serum Tg and/or ATg levels during follow-up after radioactive iodine therapy, lesion detection is performed using neck ultrasonography, thorax CT, and F-18 FDG PET/CT. Diagnostic whole-body scanning with low-dose I-131 is not routinely recommended in follow-up due to its low sensitivity and specificity.
F-18 TFB is a highly specific imaging agent for differentiated thyroid cancer, entering thyroid follicular epithelial cells via the sodium-iodide symporter (NIS), which is expressed on the cell surface and functions through a mechanism similar to that of I-131. As a PET radiotracer, F-18 TFB has been shown to be superior to I-131 in previous studies.
The primary aim of this study is to comparatively evaluate the role of F-18 TFB PET/CT versus the standard imaging modality F-18 Fluorodeoxyglucose (FDG) PET/CT in lesion detection in patients with differentiated thyroid cancer who demonstrate elevated serum Tg and/or ATg levels during follow-up after radioactive iodine therapy.
The secondary aims are to investigate the factors predicting F-18 TFB PET/CT positivity and to assess the relationship between the semi-quantitative and quantitative parameters derived from F-18 TFB PET/CT and serum thyroglobulin (Tg) and anti-thyroglobulin (ATg) levels.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Having undergone surgery for differentiated thyroid cancer and received radioactive iodine therapy
Being evaluated for lesion detection due to elevated serum Tg and/or ATg levels during post-treatment follow-up
Negative or equivocal I-131 whole-body scan findings
Karnofsky Performance Status ≥ 50 (or equivalent Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] performance status)
Disqualifiers
Age under 18 years
Pregnancy or breastfeeding
Failure to provide written informed consent
Trial design
Design model
Single group
Treatments tested in this trial
F-18-Tetrafluoroborate PET/CT
Diagnostic testF-18-Tetrafluoroborate whole body PET/CT
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: F-18-TFB PET/CT armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of F-18-TFB PET/CT
Comparative evaluation of the the diagnsotic accuracy of F-18 Tetrafluoroborate (TFB) PET/CT versus the standard imaging modality F-18 Fluorodeoxyglucose (FDG) PET/CT in lesion detection in patients with differentiated thyroid cancer who exhibit elevated serum Tg/ATg levels during follow-up after radioactive iodine therapy. Histopathology and/or clinical follow up results will be the gold standard for lesion based and patient based analysis.
Time frame
From enrollment of the first patient, 9 monthsSecondary outcomes
1
F-18 TFB PET/CT positivity
18F-TFB PET/CT positivity was evaluated at both the patient and lesion levels. Patient-based positivity was defined as the presence of at least one focal area of increased radiotracer uptake exceeding surrounding physiological background activity and considered suspicious for disease involvement on visual assessment, with corresponding structural abnormality on CT. Patients were classified as PET-positive or PET-negative (binary outcome). Clinical, biochemical, and histopathological variables were analyzed to identify independent predictors of patient-level PET positivity using univariable and multivariable regression analyses.
Time frame
From enrollment of the first patient, 9 months2
Correlation Between 18F-TFB PET/CT SUVmax (g/mL) and Serum Thyroglobulin Concentration (ng/mL)
Assessment of the correlation between lesion-based maximum standardized uptake value (SUVmax, g/mL) measured on 18F-TFB PET/CT and serum thyroglobulin (Tg) concentration (ng/mL), using Spearman or Pearson correlation analysis as appropriate.
Time frame
From enrollment of the first patient, 9 months3
Correlation Between 18F-TFB PET/CT SUVmax (g/mL) and Serum Anti-Thyroglobulin Levels (IU/mL)
Assessment of the correlation between lesion-based SUVmax (g/mL) derived from 18F-TFB PET/CT and serum anti-thyroglobulin (ATg) levels (IU/mL) using Spearman or Pearson correlation analysis.
Time frame
From enrollment of the first patient, 9 monthsSponsors and contacts
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Source ClinicalTrials.gov