Clinical trial · Observational
Evaluation of 18F-TFB PET/CT Scan in Patients With Differentiated Thyroid Cancer
Evaluation of F-18 Tetrafluoroborate (18F-TFB) PET/CT in Patients With Differentiated Thyroid Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Why stopped (as posted): Slow accrual; lack of eligible study participants
Summary
Brief summary (as posted)
This phase II study evaluates F-18 tetrafluoroborate (18F-TFB) PET/CT scan in patients with differentiated thyroid cancer. Diagnostic imaging is necessary for planning treatment, monitoring therapy response, and identifying sites of recurrent or metastatic disease in differentiated thyroid cancer. 18F-TFB PET/CT may accurately detect recurrent and metastatic thyroid cancer lesions, with the potential to provide information for patient management that is better than the current standard of care imaging practices.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Differentiated Thyroid Gland Carcinoma | Differentiated Thyroid Gland Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Thyroid Gland Follicular Carcinoma | Thyroid Gland Follicular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Thyroid Gland Papillary Carcinoma | Thyroid Gland Papillary Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Fluorine F 18 Tetrafluoroborate | Radiation | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (18F-TFB PET/CT)
- description
- Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study.
- interventionNames
- Procedure: Computed Tomography
- Radiation: Fluorine F 18 Tetrafluoroborate
- Procedure: Positron Emission Tomography
- Other: Survey Administration
Primary outcomes (2)
- measure
- Descriptive summaries of detected lesions
- timeFrame
- Up to 2 years
- description
- Descriptive summaries of detected lesions (presence/absence) will include counts and proportions at the patient and lesion level. Overall concordance of these measures across modalities will be estimated using Cohen's kappa with 95% confidence intervals generated by clustered bootstrapping. Per-lesion analysis of detection rates by modality will be performed using cluster-adjusted McNemar's test, accounting for the paired nature of the data (i.e., two scans) and potential within-sample correlation for patients with multiple lesions.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject has biopsy-proven papillary or follicular thyroid cancer * Subject is clinically indicated for 123I-SPECT/CT total body iodine (TBI) scan * Subject agrees to undergo 18F-TFB PET/CT scan following TBI scan * Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent) * Subject is able to be scanned - able to lie still on SPECT/CT and PET/CT scanner table for up to 65 minutes (min) * Age 18 or older * Ability to understand a written informed consent document, and the willingness to sign it * Subject is not pregnant Exclusion Criteria: * Contrast-enhanced CT within 4 last weeks * Amiodarone within last 4 months * Ingested iodine, kelp tablets, Lugols iodine, or potassium iodide (SSKI) within 2 weeks * Unable to lie flat, still or tolerate a PET scan * Applied betadine, iodoform, or quick tanning products to skin within last two weeks * If using medication withdrawal for stimulation, then exclude if thyroid stimulating hormone (TSH) level \< 25 * Taken anti-thyroid medication within 1 week * Subject is breastfeeding * Positive pregnancy test
References
Publications (0)
Data not yet available