GliomaNCT06563024
18F-FET PET/CT in the Management of Glioma
A study testing 18F-FET PET/CT in people with Glioma, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) is a tracer for positron emission tomography (PET). The Response Assessment in Neuro-Oncology (RANO) working group has officially recommended 18F-FET PET in the management of patients with brain glioma. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Glioma
- What is being tested?
- 18F-FET PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary or recurrent brain tumors confirmed by pathological examination or imaging studies.
- The ability to provide written informed consent and receive the scheduled scan.
Who cannot join
- Woman with pregnancy or during lactation.
- Unsuitable for PET scans, such as those with claustrophobia or inability to lie flat.
- Unable to sign the informed consent form.
- Patients with a second primary tumor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Investigation in the Utility of Multiparametric 18F-FET PET/CT in the Management of Glioma: Application of PET Radiomics
O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) is a tracer for positron emission tomography (PET). The Response Assessment in Neuro-Oncology (RANO) working group has officially recommended 18F-FET PET in the management of patients with brain glioma. Recently, the utility of 18F-FET PET in the diagnosis of fresh and residual gliomas has been reported by several investigators. But clinical usefulness of radiomics parameters has not been explored thoroughly in glioma patients. 18F-FET PET has been widely used in clinical studies or routine service in Europe, America, Mainland China, or Japan. However, 18F-FET PET is still not available in Taiwan. In this context, the investigator propose this study to explore the role of multiparametric 18F-FET PET imaging for glioma in Taiwan, with the emphasis in radiomics analysis.
Read the detailed description
Study background:
O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) is a tracer for positron emission tomography (PET). The Response Assessment in Neuro-Oncology (RANO) working group has officially recommended 18F-FET PET in the management of patients with brain glioma. Recently, the utility of 18F-FET PET in the diagnosis of fresh and residual gliomas has been reported by several investigators. But clinical usefulness of radiomics parameters has not been explored thoroughly in glioma patients. 18F-FET PET has been widely used in clinical studies or routine service in Europe, America, Mainland China, or Japan. However, 18F-FET PET is still not available in Taiwan. In this context, the investigator propose this study to explore the role of multiparametric 18F-FET PET imaging for glioma in Taiwan.
Materials and methods:
- During the pre-treatment work-up, the study participants undergo an 18F-FET PET/CT scan. In addition, other routine examinations, including MRI with and without contrast enhancement, are performed.
- After a definitive diagnosis of primary/recurrent glioma is confirmed, subjects begin treatment (surgery, radiation therapy, chemotherapy, etc.). Within 3 to 6 months after completing treatment, the study subjects undergo a second 18F-FET PET/CT scan for response evaluation, along with a follow-up MRI.
- Conditions
- Glioma
- Being tested
- 18F-FET PET/CT
- Keywords
- Glioma, 18F-FET, PET
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FET PET/CTDevice
The enrolled patients receive the 18F-FET PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FET PET | Experimental | The study participants receive the 18F-FET PET scan. Receives: Device: 18F-FET PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival is measured from the date of diagnosis to the date of death, or censored at last follow-up date.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Aug 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheng-Chieh Chan, Study director, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563024
- Sponsor's protocol ID
- IRB108-262-A
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan SC, Chiu TL, Ng SH, Kao HW, Tsai ST, Liu SH. 18F-FET PET/CT can aid in diagnosing patients with indeterminate MRI findings for brain tumors: a prospective study. Ann Nucl Med. 2025 Apr;39(4):342-352. doi: 10.1007/s12149-024-02005-4. Epub 2024 Nov 26.
PubMed 39589672
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Investigation in the Utility of Multiparametric 18F-FET PET/CT in the Management of Glioma: Application of PET Radiomics
- ClinicalTrials.gov ID
- NCT06563024
- Acronym / sponsor ID
- IRB108-262-A
- Conditions
- Glioma
- Keywords
- Glioma, 18F-FET, PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 20 Aug 2024 (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.
O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) is a tracer for positron emission tomography (PET). The Response Assessment in Neuro-Oncology (RANO) working group has officially recommended 18F-FET PET in the management of patients with brain glioma. Recently, the utility of 18F-FET PET in the diagnosis of fresh and residual gliomas has been reported by several investigators. But clinical usefulness of radiomics parameters has not been explored thoroughly in glioma patients. 18F-FET PET has been widely used in clinical studies or routine service in Europe, America, Mainland China, or Japan. However, 18F-FET PET is still not available in Taiwan. In this context, the investigator propose this study to explore the role of multiparametric 18F-FET PET imaging for glioma in Taiwan, with the emphasis in radiomics analysis.
Detailed description
Study background:
O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) is a tracer for positron emission tomography (PET). The Response Assessment in Neuro-Oncology (RANO) working group has officially recommended 18F-FET PET in the management of patients with brain glioma. Recently, the utility of 18F-FET PET in the diagnosis of fresh and residual gliomas has been reported by several investigators. But clinical usefulness of radiomics parameters has not been explored thoroughly in glioma patients. 18F-FET PET has been widely used in clinical studies or routine service in Europe, America, Mainland China, or Japan. However, 18F-FET PET is still not available in Taiwan. In this context, the investigator propose this study to explore the role of multiparametric 18F-FET PET imaging for glioma in Taiwan.
Materials and methods:
- During the pre-treatment work-up, the study participants undergo an 18F-FET PET/CT scan. In addition, other routine examinations, including MRI with and without contrast enhancement, are performed.
- After a definitive diagnosis of primary/recurrent glioma is confirmed, subjects begin treatment (surgery, radiation therapy, chemotherapy, etc.). Within 3 to 6 months after completing treatment, the study subjects undergo a second 18F-FET PET/CT scan for response evaluation, along with a follow-up MRI.
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 | Experimental | Device: 18F-FET PET/CTThe study participants receive the 18F-FET PET scan. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary or recurrent brain tumors confirmed by pathological examination or imaging studies.
- The ability to provide written informed consent and receive the scheduled scan.
Key exclusion criteria (4 listed)
- Woman with pregnancy or during lactation.
- Unsuitable for PET scans, such as those with claustrophobia or inability to lie flat.
- Unable to sign the informed consent form.
- Patients with a second primary tumor.
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-FET PET/CTThe enrolled patients receive the 18F-FET PET/CT. | Device | 18F-FET PET |
Primary outcome
Overall survival
Time frame: 3 years
Overall survival is measured from the date of diagnosis to the date of death, or censored at last follow-up date.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Derived from this study: PubMed 39589672Chan SC, Chiu TL, Ng SH, Kao HW, Tsai ST, Liu SH. 18F-FET PET/CT can aid in diagnosing patients with indeterminate MRI findings for brain tumors: a prospective study. Ann Nucl Med. 2025 Apr;39(4):342-352. doi: 10.1007/s12149-024-02005-4. Epub 2024 Nov 26.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sheng-Chieh Chan study director
Hualien Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FET PET/CT in people with Glioma, run by Buddhist Tzu Chi General Hospital at 1 site 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06563024, which also lists 1 linked publication.
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 20 Aug 2024.