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Recruiting NCT07436455

F-18 Tetrafluoroborate PET/CT in Differentiated Thyroid Cancer

No phase Interventional Thyroid Cancer Differentiated Thyroid Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: F-18-Tetrafluoroborate PET/CT.
Who it may be relevant to
Registry conditions: Thyroid Cancer, Differentiated Thyroid Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 test F-18-Tetrafluoroborate PET/CT
    F-18-Tetrafluoroborate whole body PET/CT

Primary outcome measures

  • Diagnostic accuracy of F-18-TFB PET/CT [Time frame: From enrollment of the first patient, 9 months]
Secondary outcome measures (3)
  • F-18 TFB PET/CT positivity [Time frame: From enrollment of the first patient, 9 months]
  • Correlation Between 18F-TFB PET/CT SUVmax (g/mL) and Serum Thyroglobulin Concentration (ng/mL) [Time frame: From enrollment of the first patient, 9 months]
  • Correlation Between 18F-TFB PET/CT SUVmax (g/mL) and Serum Anti-Thyroglobulin Levels (IU/mL) [Time frame: From enrollment of the first patient, 9 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Turkey (Türkiye) · 2 centers
  • Ankara University Medical School Nuclear Medicine Department — Ankara
  • Hacettepe University Medical School Nuclear Medicine Department — Ankara

Identifiers

NCT: NCT07436455 · i06-456-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗