Thyroid CancerNISDETECTNCT07436455
F-18 Tetrafluoroborate PET/CT in Differentiated Thyroid Cancer
A study testing F-18-Tetrafluoroborate PET/CT in people with Thyroid Cancer and Differentiated Thyroid Cancer, run by Ankara University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Differentiated Thyroid Cancer
- What is being tested?
- F-18-Tetrafluoroborate PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age under 18 years
- Pregnancy or breastfeeding
- Failure to provide written informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara University Medical School Nuclear Medicine Department
Ankara, Ankara, 06590
Mine Araz, Assoc.Prof.Dr., +905326667313, minesoylu@yahoo.com
Nuriye Ozlem Küçük, Prof.Dr.
- Recruiting
Hacettepe University Medical School Nuclear Medicine Department
Ankara, Ankara, 06590
Murat Fani Bozkurt, Prof.Dr., 05326667313 ext. +905324924890, fanibozkurt@gmail.com
Bilge Volkan Salancı, Prof.Dr.
About this study
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.
Read more
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.
- Conditions
- Thyroid Cancer, Differentiated Thyroid Cancer
- Being tested
- F-18-Tetrafluoroborate PET/CT
- Keywords
- F-18-tetrafluoroborate, PET/CT, NIS
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18-Tetrafluoroborate PET/CTDiagnostic test
F-18-Tetrafluoroborate whole body PET/CT
| Study group | Role | What they receive |
|---|---|---|
| F-18-TFB PET/CT arm | Experimental | DTC patients who underwent F-18-TFB PET/CT Receives: Diagnostic Test: F-18-Tetrafluoroborate PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment of the first patient, 9 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From enrollment of the first patient, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Nov 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine Araz, Ankara University
- Investigators
- Mine Araz, Assoc.Prof., Principal investigator, Ankara University Medical School Nuclear Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436455
- Sponsor's protocol ID
- i06-456-25
- Acronym
- NISDETECT
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F-18 Tetrafluoroborate PET/CT in Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT07436455
- Acronym / sponsor ID
- NISDETECT / i06-456-25
- Conditions
- Thyroid Cancer, Differentiated Thyroid Cancer
- Keywords
- F-18-tetrafluoroborate, PET/CT, NIS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F-18-TFB PET/CT arm | Experimental | Diagnostic Test: F-18-Tetrafluoroborate PET/CTDTC patients who underwent F-18-TFB PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Age under 18 years
- Pregnancy or breastfeeding
- Failure to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-18-Tetrafluoroborate PET/CTF-18-Tetrafluoroborate whole body PET/CT | Diagnostic test | F-18-TFB PET/CT arm |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mine Araz, Assoc.Prof. principal investigator
Ankara University Medical School Nuclear Medicine Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-18-Tetrafluoroborate PET/CT in people with Thyroid Cancer and Differentiated Thyroid Cancer, run by Ankara University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mine Araz, Assoc.Prof.Dr. (+905326667313, minesoylu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of F-18-TFB PET/CT (time frame: From enrollment of the first patient, 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.