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Recruiting NCT05575440

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

— Observational Differentiated Thyroid Gland Carcinoma Thyroid Gland Follicular Carcinoma Thyroid Gland Papillary Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computed Tomography, Fluorine F 18 Tetrafluoroborate, Positron Emission Tomography, Survey Administration.
Who it may be relevant to
Registry conditions: Differentiated Thyroid Gland Carcinoma, Thyroid Gland Follicular Carcinoma, Thyroid Gland Papillary Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

PRIMARY OBJECTIVES:

I. 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.

Interventions

  • Procedure Computed Tomography
    Undergo a PET/CT scan
  • Radiation Fluorine F 18 Tetrafluoroborate
    Given IV
  • Procedure Positron Emission Tomography
    Undergo a PET/CT scan
  • Other Survey Administration
    Ancillary studies

Primary outcome measures

  • Descriptive summaries of detected lesions [Time frame: Up to 2 years]
  • Conspicuities and diagnostic confidence scores for a given lesion [Time frame: Up to 2 years]
Secondary outcome measures (3)
  • True positive and negative lesions [Time frame: Up to 2 years]
  • Impact of PET on clinical management in differentiated thyroid cancer (DTC) patients [Time frame: Up to 2 years]
  • Inter-reader reproducibility [Time frame: Up to 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT05575440 · 20-010573 · NCI-2022-03071

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗