Differentiated Thyroid Cancer, Thyroid Cancer
Conditions
Keywords
F-18-tetrafluoroborate, PET/CT, NIS
Brief summary
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.
Interventions
DIAGNOSTIC_TESTF-18-Tetrafluoroborate PET/CT
F-18-Tetrafluoroborate whole body PET/CT
Sponsors
Ankara University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * Giving written informed consent
Exclusion criteria
* Age under 18 years * Pregnancy or breastfeeding * Failure to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of F-18-TFB PET/CT | From enrollment of the first patient, 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| F-18 TFB PET/CT positivity | From enrollment of the first patient, 9 months | 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. |
| Correlation Between 18F-TFB PET/CT SUVmax (g/mL) and Serum Thyroglobulin Concentration (ng/mL) | From enrollment of the first patient, 9 months | 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. |
| Correlation Between 18F-TFB PET/CT SUVmax (g/mL) and Serum Anti-Thyroglobulin Levels (IU/mL) | From enrollment of the first patient, 9 months | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMine Araz, Assoc.Prof.Dr.
PRINCIPAL_INVESTIGATORMine Araz, Assoc.Prof.
Ankara University Medical School Nuclear Medicine Department
Outcome results
None listed