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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F-18-TFB PET/CT arm | Experimental | DTC patients who underwent F-18-TFB PET/CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-18-Tetrafluoroborate PET/CT | Diagnostic Test | F-18-Tetrafluoroborate whole body PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment of the first patient, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mine Araz, Assoc.Prof.Dr. | Contact | +905326667313 | minesoylu@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mine Araz, Assoc.Prof. | Ankara University Medical School Nuclear Medicine Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University Medical School Nuclear Medicine Department | Recruiting | Ankara | Ankara | 06590 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| From enrollment of the first patient, 9 months |
| 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. | From enrollment of the first patient, 9 months |
| 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. | From enrollment of the first patient, 9 months |
| Hacettepe University Medical School Nuclear Medicine Department | Recruiting | Ankara | Ankara | 06590 | Turkey (Türkiye) |
|
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |