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

Recruiting

• Conditions: Differentiated Thyroid Gland Carcinoma; Thyroid Gland Follicular Carcinoma; Thyroid Gland Papillary Carcinoma

• Registration Number: NCT05575440
• Lead Sponsor: Mayo Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Inclusion Criteria:<br><br> - Subject has biopsy-proven papillary or follicular thyroid cancer<br><br> - Subject is clinically indicated for 123I-SPECT/CT total body iodine (TBI) scan<br><br> - Subject agrees to undergo 18F-TFB PET/CT scan following TBI scan<br><br> - Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group<br> [ECOG]/World Health Organization [WHO] equivalent)<br><br> - Subject is able to be scanned - able to lie still on SPECT/CT and PET/CT scanner<br> table for up to 65 minutes (min)<br><br> - Age 18 or older<br><br> - Ability to understand a written informed consent document, and the willingness to<br> sign it<br><br> - Subject is not pregnant<br><br>Exclusion Criteria:<br><br> - Contrast-enhanced CT within 4 last weeks<br><br> - Amiodarone within last 4 months<br><br> - Ingested iodine, kelp tablets, Lugols iodine, or potassium iodide (SSKI) within 2<br> weeks<br><br> - Unable to lie flat, still or tolerate a PET scan<br><br> - Applied betadine, iodoform, or quick tanning products to skin within last two weeks<br><br> - If using medication withdrawal for stimulation, then exclude if thyroid stimulating<br> hormone (TSH) level < 25<br><br> - Taken anti-thyroid medication within 1 week<br><br> - Subject is breastfeeding<br><br> - Positive pregnancy test

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Descriptive summaries of detected lesions;Conspicuities and diagnostic confidence scores for a given lesion

Secondary Outcome Measures

Name	Time	Method
True positive and negative lesions;Impact of PET on clinical management in differentiated thyroid cancer (DTC) patients;Inter-reader reproducibility