[18F]Tetrafluoroborate PET/CT for detecting differentiated thyroid cancer: phase-II study protocol.

AIMS: This study aims to evaluate the diagnostic potential of [18F]TFB PET/CT for detecting pre-operative lymph node metastases and predicting [131I] therapy response in differentiated thyroid cancer (DTC).

METHODS

This prospective, multicenter phase-2 clinical trial includes adult patients with DTC and pathologically confirmed cervical lymph node metastases scheduled for thyroidectomy and lymph node dissection (Group 1) and patients with recurrent or persistent DTC scheduled for radioiodine therapy (Group 2). [18F]TFB PET/CT will be compared to current imaging modalities and post-therapy scintigraphy. Primary outcomes include optimal imaging time points, sensitivity, specificity, SUVmax, and TBRmax for lymph node metastases and suspected lesions. Secondary outcomes involve [18F]TFB kinetics, NIS expression correlation, and safety profiles. In conclusion, [18F]TFB PET/CT holds the potential for enhancing pre-operative lymph node metastasis detection and predicting [131I] therapy response, potentially improving surgical and therapeutic outcomes for DTC patients.