Clinical Benefit of 18F-FET in Glioma.

This Phase II clinical trial, sponsored by **Primo Biotechnology Co., Ltd.**, evaluates the clinical benefit of **$^{18}$F-FET PET/CT** in diagnosing glioma. The study aims to compare the diagnostic performance of $^{18}$F-FET PET imaging against traditional brain MRI, using surgical histopathology as the gold standard for verification.

**Study Design and Participants** This is a single-center, open-label, non-randomized trial conducted in Taiwan. The study will enroll a total of **36 participants**, consisting of 6 healthy volunteers (to assess biodistribution and dosimetry) and 30 patients with suspected primary gliomas scheduled for surgery.

**Methodology** The test drug, $^{18}$F-FET, is a radiopharmaceutical that targets large neutral amino acid transporters (LAT). It is administered via intravenous injection at a dosage of 3MBq/kgw.

* **Volunteers** undergo PET/CT scans immediately and every 20 minutes for 90 minutes. * **Patients** receive a static PET scan 40-50 minutes post-injection.

**Endpoints and Safety**

* **Primary Endpoint:** Diagnostic sensitivity compared to MRI. * **Secondary Endpoints:** Specificity, PPV, NPV, tumor-to-background ratios (TBR), and safety (adverse events/vital signs). * **Radiation Safety:** The total estimated radiation exposure is **7.63 mSv**, which is well below the international safety threshold of 100 mSv.

**Conclusion** The trial seeks to establish $^{18}$F-FET PET/CT as a safe and effective diagnostic tool for the pre-surgical assessment of gliomas, potentially providing higher sensitivity and more accurate lesion detection than conventional MRI in Asian cancer patients.