NCT07436455

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Nov 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Nov 2025Oct 2026

Study Start

First participant enrolled

November 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 15, 2026

Last Update Submit

February 21, 2026

Conditions

Thyroid CancerDifferentiated Thyroid Cancer

Keywords

F-18-tetrafluoroboratePET/CTNIS

Outcome Measures

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.

    From enrollment of the first patient, 9 months

Secondary Outcomes (3)

  • F-18 TFB PET/CT positivity

    From enrollment of the first patient, 9 months

  • Correlation Between 18F-TFB PET/CT SUVmax (g/mL) and Serum Thyroglobulin Concentration (ng/mL)

    From enrollment of the first patient, 9 months

  • Correlation Between 18F-TFB PET/CT SUVmax (g/mL) and Serum Anti-Thyroglobulin Levels (IU/mL)

    From enrollment of the first patient, 9 months

Study Arms (1)

F-18-TFB PET/CT arm

EXPERIMENTAL

DTC patients who underwent F-18-TFB PET/CT

Diagnostic Test: F-18-Tetrafluoroborate PET/CT

Interventions

F-18-Tetrafluoroborate PET/CTDIAGNOSTIC_TEST

F-18-Tetrafluoroborate whole body PET/CT

F-18-TFB PET/CT arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age under 18 years
  • Pregnancy or breastfeeding
  • Failure to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ankara University Medical School Nuclear Medicine Department

Ankara, Ankara, 06590, Turkey (Türkiye)

RECRUITING

Hacettepe University Medical School Nuclear Medicine Department

Ankara, Ankara, 06590, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Mine Araz, Assoc.Prof.

    Ankara University Medical School Nuclear Medicine Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mine Araz, Assoc.Prof.Dr.

CONTACT

+905326667313minesoylu@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.Dr. Mine Araz

Study Record Dates

First Submitted

February 15, 2026

First Posted

February 27, 2026

Study Start

November 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)