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Differentiated Thyroid Gland CarcinomaNCT05575440

Evaluation of 18F-TFB PET/CT Scan in Patients With Differentiated Thyroid Cancer

An observational study of Differentiated Thyroid Gland Carcinoma and Thyroid Gland Follicular Carcinoma, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed Tomography, Fluorine F 18 Tetrafluoroborate and Positron Emission Tomography
How many people
11 participants
Where
1 siteUnited States
Study dates
22 Apr 2022to 29 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

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

Study population: 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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Taken anti-thyroid medication within 1 week
  • Subject is breastfeeding
  • Positive pregnancy test

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Evaluation of F-18 Tetrafluoroborate (18F-TFB) PET/CT in Patients With Differentiated Thyroid Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Evaluate fluorine F 18 tetrafluoroborate (18F-TFB) positron emission tomography (PET)/computed tomography (CT) imaging in patients with intermediate or high risk differentiated thyroid cancer (DTC) and compare to the current clinical standard.

II. Assess the impact of 18F-TFB PET/CT on clinical management.

OUTLINE:

Patients receive fluorine F 18 tetrafluoroborate intravenously (IV) and undergo PET/CT scan on study.

Being tested
Computed Tomography, Fluorine F 18 Tetrafluoroborate, Positron Emission Tomography, Survey Administration
Medical subject headings
Adenocarcinoma, Follicular, Thyroid Cancer, Papillary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo a PET/CT scan

  • Fluorine F 18 TetrafluoroborateRadiation

    Also called 18F-Tetrafluoroborate, 18F-TFB

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo a PET/CT scan

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT05575440
Study groupRoleWhat they receive
Observational (18F-TFB PET/CT)Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study.
Receives: Procedure: Computed Tomography; Radiation: Fluorine F 18 Tetrafluoroborate; Procedure: Positron Emission Tomography; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

Secondary outcomes (3)

  1. True positive and negative lesions

    Given true positive and negative lesions determined by histopathology and/or imaging, clinical and laboratory follow-up, we will estimate sensitivity, specificity, net present value, and positive predictive value on a per-lesion and patient basis for 18F TFB PET/CT and 123I single-photon emission computerized tomography/CT along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using clustered bootstrapping.

    Measured: Up to 2 years

  2. Impact of PET on clinical management in differentiated thyroid cancer (DTC) patients

    The impact of PET on clinical management in DTC patients will be evaluated using descriptive statistics. Evidence of discordance among the modalities will be assessed using a McNemar- Bowker test of symmetry.

    Measured: Up to 2 years

  3. Inter-reader reproducibility

    Inter-reader reproducibility will be assessed for positivity at the patient level and region level (nominal) as well as standardized uptake values (SUVs) for positive lesions (quantitative). Reproducibility will be reported using the Fleiss' Kappa test for multiple readers for positivity and Pearson intra-class correlation for SUVs.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2022
  2. Study start22 Apr 2022
  3. Primary completion29 Jul 2026
  4. Study completion29 Jul 2026

Why it stopped: Slow accrual; lack of eligible study participants

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05575440
Sponsor's protocol ID
20-010573
Other IDs
NCI-2022-03071
Status last verified
Sep 2026
First submitted
7 Oct 2022
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Differentiated Thyroid Gland Carcinoma and Thyroid Gland Follicular Carcinoma, run by Mayo Clinic at 1 site in United States.

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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

The study was stopped early (reason given: Slow accrual; lack of eligible study participants). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Descriptive summaries of detected lesions (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05575440.

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 24 Sep 2026.

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