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
2 other identifiers
observational
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2022
CompletedFirst Submitted
Initial submission to the registry
October 7, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
February 27, 2026
February 1, 2026
6 years
October 7, 2022
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Descriptive summaries of detected lesions
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.
Up to 2 years
Conspicuities and diagnostic confidence scores for a given lesion
Conspicuities and diagnostic confidence scores for a given lesion will be averaged across readers. Descriptive summaries of these scores will include medians and interquartile ranges. Concordance of these measures across modality will be evaluated using Lin's concordance correlation coefficient with 95% confidence intervals generated by clustered bootstrapping. Differences in conspicuities and diagnostic confidence scores will be tested using cluster-adjusted Wilcoxon signed-rank tests.
Up to 2 years
Secondary Outcomes (3)
True positive and negative lesions
Up to 2 years
Impact of PET on clinical management in differentiated thyroid cancer (DTC) patients
Up to 2 years
Inter-reader reproducibility
Up to 2 years
Study Arms (1)
Observational (18F-TFB PET/CT)
Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study.
Interventions
Undergo a PET/CT scan
Undergo a PET/CT scan
Given IV
Eligibility Criteria
Subjects have biopsy-proven papillary or follicular thyroid cancer and is clinically indicated for 123I-single-photon emission computerized tomography (I-SPECT)/CT total body iodine (TBI) scan
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen M. Broski, M.D.
Mayo Clinic in Rochester
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2022
First Posted
October 12, 2022
Study Start
April 22, 2022
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
February 27, 2026
Record last verified: 2026-02