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A scan called 18F-FET PET tested for finding glioma before surgery

Official title: Clinical Benefit of 18F-FET in Glioma.

The short version

This study tests whether a special brain scan can show a gliomaglioma: A tumor that starts in the glial cells, the support cells of the brain and spinal cord. Gliomas are graded 1 to 4 by how fast they tend to grow. See the glossary more clearly than an MRI does.

Read our full plain-language summary

What the trial team says

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

Registry number

NCT07698457

Stage of testing

Phase 3

Conditions studied

Glioma, 18F-Fluoroethyl-l-tyrosine

Where it is running

This trial lists 4 sites.

• Fuxing St., Guishan Dist.
  • Linkou Chang Gung Memorial Hospital (Taoyuan City)
• Maijin Rd., Anle Dist.
  • Keelung Chang Gung Memorial Hospital (Keelung)
• Puzi City
  • Chiayi Chang Gung Memorial Hospital (Chiayi City)
• Taiwan
  • Kaohsiung Chang Gung Memorial Hospital (Kaohsiung City)

This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.