Clinical Benefit of 18F-FET in Glioma.

Sponsor
Primo Biotechnology Co., Ltd
Study ID
NCT07698457
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • 18F-Fluoroethyl-l-tyrosine
  • Glioma

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 18F-Fluoroethyl-l-tyrosine — DIAGNOSTIC_TEST
    18F-FET PET imaging

Study Details

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 Dates

First listed
Jul 13, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 18F-FET PET imaging

Primary Outcome Measure

Accuracy Rate [ Time Frame: 12 months ]

Central Contacts

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