Clinical Benefit of 18F-FET in Glioma.

Official title

The Clinical Benefit of 18F-Fluoroethyl-l-tyrosine(FET) PET/CT in Glioma Patients.

Overview

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.

Interventions

• Diagnostic test 18F-Fluoroethyl-l-tyrosine
  18F-FET PET imaging

Primary outcome measures

• Accuracy Rate [Time frame: 12 months]

Secondary outcome measures (3)

• Positive detection Rate [Time frame: 12months]
• AE incidence rate [Time frame: 7 weeks]
• SUVmean in major normal organ [Time frame: 1 day]

Eligibility criteria

• Inclusion criteria： For health volunteers

• Participants must be ≥ 20 years old.
• Participants are alert and oriented, and able to independently sign ICF. For glioma patients

<!-- -->

• Participants must be ≥ 20 years old.
• Participants with suspected primary gliomas scheduled for surgery.
• Participants are alert and oriented, and able to independently sign ICF.
• Exclusion criteria：

• Liver dysfunction within the past 6 months (e.g., AST/ALT ratio > 2, total bilirubin > 1.5 mg/dL).
• Chronic kidney disease stage 4 (eGFR < 30 mL/min/1.73 m2) within the last 6 months.
• Acute kidney injury within the past 6 months.
• Allergic to any radiopharmaceuticals or contrast agents.
• Restlessness or inability to lie in a cast for 30 to 60 minutes.
• Women who are pregnant, lactating, or planning pregnancy during the study period or before screening.
• PI deemed the participant unsuitable.
• The patient is not able to understand the treatment options.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Taiwan · 4 centers

• Linkou Chang Gung Memorial Hospital — Taoyuan City
• Keelung Chang Gung Memorial Hospital — Keelung
• Chiayi Chang Gung Memorial Hospital — Chiayi City
• Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City

Identifiers

NCT: NCT07698457 · CBFETglio

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗