Clinical Benefit of 18F-FET in Glioma.

ClinicalTrials.gov ID

NCT07698457

Lead Sponsor

Primo Biotechnology Co., LtdINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

36Estimated

Last Update Posted

Jul 13, 2026Actual

Start Date

Oct 1, 2026Estimated

Primary Completion Date

Nov 30, 2027Estimated

Completion Date

Jan 31, 2028Estimated

Official Title

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

Brief Summary

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.

• Glioma
• 18F-Fluoroethyl-l-tyrosine

• 18F-Fluoroethyl-l-tyrosine

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

• Inclusion criteria： For health volunteers

  1. Participants must be ≥ 20 years old.
  2. Participants are alert and oriented, and able to independently sign ICF. For glioma patients
  1. Participants must be ≥ 20 years old.
  2. Participants with suspected primary gliomas scheduled for surgery.
  3. Participants are alert and oriented, and able to independently sign ICF.

• Exclusion criteria：

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

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Primo Biotechnology Co., LtdINDUSTRY

Collaborators

Chang Gung Memorial HospitalOTHER

kuochenwei@cgmh.org.tw+886 0224313131 ext. 6252

cchsu128@gmail.con+886 05362100 ext. 2604

m7217@cgmh.org.tw+886 077317123 ext. 8011

• 18F-FET PET/CT in the Management of Glioma

  NCT06563024

  CompletedInterventionalNot ApplicableUpdated Aug 20, 2024
• 18F-FET-PET/MRI vs Standard MRI Alone for Stereotactic RadioTherapy Planning for High Grade Brain Gliomas

  NCT06499831

  Unknown statusInterventionalNot ApplicableUpdated May 25, 2025
• FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma

  NCT06172595

  RecruitingInterventionalPhase 2Updated Dec 3, 2024
• [18F]FET PET for Characterization of Progressive or Recurrent Glioma From Treatment Related Changes

  NCT07238322

  CompletedObservationalUpdated May 15, 2026
• Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms

  NCT04044937

  CompletedInterventionalPhase 2Updated Mar 11, 2026
• 18F-FET PET in Childhood Brain Tumours

  NCT03216148

  Unknown statusInterventionalPhase 2Updated Jul 21, 2017