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

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.

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.

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