Clinical Benefit of 18F-FET in Glioma.
Starting soon · Phase 3
Conditions studied: Glioma, 18F-Fluoroethyl-l-tyrosine
In brief
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.
Key facts
- Study ID
- NCT07698457
- Run by
- Primo Biotechnology Co., Ltd
- People needed
- 36
- Starts
- 2026-10-01
- Expected to finish
- 2028-01-31
- Last updated by the study team
- 2026-07-13
Who can join
Age: 20 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Linkou Chang Gung Memorial Hospital — Taoyuan City, Fuxing St., Guishan Dist., Taiwan
- Keelung Chang Gung Memorial Hospital — Keelung, Maijin Rd., Anle Dist., Taiwan
- Chiayi Chang Gung Memorial Hospital — Chiayi City, Puzi City, Taiwan
- Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
Full record on ClinicalTrials.gov
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