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

Mayo Clinic

Status

Enrolling

Conditions

Differentiated Thyroid Gland Carcinoma

Thyroid Gland Follicular Carcinoma

Thyroid Gland Papillary Carcinoma

Treatments

Procedure: Computed Tomography

Other: Survey Administration

Radiation: Fluorine F 18 Tetrafluoroborate

Procedure: Positron Emission Tomography

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05575440

NCI-2022-03071 (Registry Identifier)

20-010573 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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