GliomaPhase 3NCT07698457
Clinical Benefit of 18F-FET in Glioma.
A Phase 3 study testing 18F-Fluoroethyl-l-tyrosine in people with Glioma and 18F-Fluoroethyl-l-tyrosine, run by Primo Biotechnology Co., Ltd at 4 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioma, 18F-Fluoroethyl-l-tyrosine
- What is being tested?
- 18F-Fluoroethyl-l-tyrosine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesTaiwan
- Study dates
- 1 Oct 2026to 31 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan4 sites
Chiayi Chang Gung Memorial Hospital
Chiayi City, Puzi City, 613016
Chien-Chin Hsu, +886 05362100 ext. 2604, cchsu128@gmail.con
Chien-Chin Hsu
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833401
Ming-Jung Chuang, +886 077317123 ext. 8011, m7217@cgmh.org.tw
Yen-Hsiang Chang, 886-0975056631, changyh@cgmh.org.tw
Keelung Chang Gung Memorial Hospital
Keelung, Maijin Rd., Anle Dist., 204
Ko-Ting Chen, +886 0224313131 ext. 6252, kuochenwei@cgmh.org.tw
Tsung-Ying Ho, +886 0224313131 ext. 2239, albertyho@gmail.com
Linkou Chang Gung Memorial Hospital
Taoyuan City, Fuxing St., Guishan Dist., 333423
Kuo-Chen Wei, +886 033281200#2412.2119, kuochenwei@cgmh.org.tw
Ko-Ting Chen, +886 033281200 ext. 3596, chenkoting@gmail.com
About this study
Official title: The Clinical Benefit of 18F-Fluoroethyl-l-tyrosine(FET) PET/CT in Glioma Patients.
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.
Read more
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.
- Conditions
- Glioma, 18F-Fluoroethyl-l-tyrosine
- Being tested
- 18F-Fluoroethyl-l-tyrosine
- Keywords
- 18F-FET, MRI, Diagnostic accuracy
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluoroethyl-l-tyrosineDiagnostic test
18F-FET PET imaging
| Study group | Role | What they receive |
|---|---|---|
| 18F-FET PET imaging | Experimental | Not described Receives: Diagnostic Test: 18F-Fluoroethyl-l-tyrosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy Rate
Measured: 12 months
Secondary outcomes (3)
Positive detection Rate
Measured: 12months
AE incidence rate
Safety
Measured: 7 weeks
SUVmean in major normal organ
Biodistribution
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primo Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698457
- Sponsor's protocol ID
- CBFETglio
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Benefit of 18F-Fluoroethyl-l-tyrosine(FET) PET/CT in Glioma Patients.
- ClinicalTrials.gov ID
- NCT07698457
- Acronym / sponsor ID
- CBFETglio
- Conditions
- Glioma, 18F-Fluoroethyl-l-tyrosine
- Keywords
- 18F-FET, MRI, Diagnostic accuracy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Primo Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FET PET imaging | Experimental | Diagnostic Test: 18F-Fluoroethyl-l-tyrosine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- <!-- -->
Key exclusion criteria (8 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-Fluoroethyl-l-tyrosine18F-FET PET imaging | Diagnostic test | 18F-FET PET imaging |
Primary outcome
Accuracy Rate
Time frame: 12 months
3 secondary outcomes
Positive detection Rate
Time frame: 12months
AE incidence rate
Time frame: 7 weeks
SUVmean in major normal organ
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 18F-Fluoroethyl-l-tyrosine in people with Glioma and 18F-Fluoroethyl-l-tyrosine, run by Primo Biotechnology Co., Ltd at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuo-Chen Wei (+886 033281200#2412.2119, kuochenwei@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.