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NCT Number: NCT07436455

F-18 Tetrafluoroborate PET/CT in Differentiated Thyroid Cancer

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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Key information

Conditions

Thyroid Cancer Differentiated Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Medical School Nuclear Medicine Department, Ankara, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

F-18-Tetrafluoroborate PET/CT

Diagnostic Test

F-18-Tetrafluoroborate whole body PET/CT

Primary outcomes

  1. Diagnostic accuracy of F-18-TFB PET/CT

    Time frame: 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 outcomes

  1. F-18 TFB PET/CT positivity

    Time frame: 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.

  2. 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

    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.

  3. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mine Araz, Assoc.Prof.Dr.

CONTACT

[email protected]

+905326667313

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Acronym: NISDETECT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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