Glioma, MalignantPhase 2FET PET in HGGNCT06172595
FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma
A Phase 2 study testing FET PET in people with Glioma, Malignant, run by Singapore General Hospital at 2 sites in Singapore.
Trial summary
The goal of this clinical trial is to evaluate the performance characteristics of O-(2-[18F]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of [18F]FET-PET in delineating… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glioma, Malignant
- What is being tested?
- FET PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesSingapore
- Study dates
- 21 Dec 2023to 28 Feb 2026
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or Women, aged 21 years or older at time of screening
- Histologically confirmed diagnosis of malignant glioma (defined as WHO grade III or IV) with previous RT to tumour
- With enlarging contrast-enhancing and/or T2W/FLAIR-hyperintense lesion(s) on MRI within the previous RT field
- Gliomas with Isocitrate dehydrogenase (IDH) wild-type status, as defined on immunohistochemistry
- Subject must consent to undergo all study procedures
Who cannot join
- Low-grade gliomas (histology grade 1 or 2 by WHO classification)16,17
- Previous bevacizumab or other vascular endothelial growth factor (VEGF) targeting agents or anti-angiogenic treatments.
- Proven cerebral metastases
- IDH-mutated gliomas
- Pregnancy/ breast-feeding
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore
Chua, 65-96779867, kevin.chua.l.m@singhealth.com.sg
- Recruiting
Singapore General Hospital
Singapore
Lam, 65-8123-0904, winnie.lam.w.c@singhealth.com.sg
Winnie W Lam, MBBS, FRCR, FAMS
About this study
Official title: 18F-FET (O-(2-[18F]Fluoroethyl)-L-tyrosine) PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Gliomas
The goal of this clinical trial is to evaluate the performance characteristics of O-(2-[18F]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of [18F]FET-PET in delineating disease. The main question[s] it aims to answer are:
- whether 18F-FET-PET will demonstrate high diagnostic accuracy to detect true tumour progression
- whether we can optimise the threshold cut-offs for TBRmax and other relevant parameters in discriminating pseudoprogression and disease progression Participants will undergo a limited 18F-FET PET/CT of the brain in SGH.
- Conditions
- Glioma, Malignant
- Being tested
- 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.
FET PETDiagnostic test
There is only one study visit during which study subjects will undergo a 18F-FET PET/CT in SGH. Following that, they will be followed up as per their routine clinical care. Data collection timepoints will be at 30 days, 4 months, 8 months and 1 year.
| Study group | Role | What they receive |
|---|---|---|
| FET PET | Experimental | Upon recruitment, a single study visit will be scheduled where subjects undergo a limited 18F-FET PET/CT of the brain in SGH.
After the study visit, from time of recruitment, they will continue their regular clinic visits as clinically indicated, where they will be monitored for at least a year for stability or deterioration. If clinically indicated, they may undergo conventional MRI, alternative MRI imaging and/or histopathological correlation in their respective primary institutions.
During these follow-up visits, any adverse effects possibly attributed to the 18F-FET PET/CT can also be flagged up.
Any alternative MRI imaging performed (as part of clinical practice in the respective primary institutions) within 4 weeks of the 18F-FET PET/CT study will also be included in the comparative analysis. Receives: Diagnostic Test: FET PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging
Sensitivity and specificity of [18F]FET-PET in delineating disease.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start21 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MalignantStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Centre, Singapore, National Neuroscience Institute Singapore, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172595
- Sponsor's protocol ID
- 202112-00050
- Acronym
- FET PET in HGG
- Status last verified
- Nov 2024
- First submitted
- 7 Dec 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FET (O-(2-[18F]Fluoroethyl)-L-tyrosine) PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Gliomas
- ClinicalTrials.gov ID
- NCT06172595
- Acronym / sponsor ID
- FET PET in HGG / 202112-00050
- Conditions
- Glioma, Malignant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Centre, Singapore, National Neuroscience Institute Singapore, Duke-NUS Graduate Medical School
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 15 Dec 2023 (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.
The goal of this clinical trial is to evaluate the performance characteristics of O-(2-[18F]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of [18F]FET-PET in delineating disease. The main question[s] it aims to answer are:
- whether 18F-FET-PET will demonstrate high diagnostic accuracy to detect true tumour progression
- whether we can optimise the threshold cut-offs for TBRmax and other relevant parameters in discriminating pseudoprogression and disease progression Participants will undergo a limited 18F-FET PET/CT of the brain in SGH.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FET PET | Experimental | Diagnostic Test: FET PETUpon recruitment, a single study visit will be scheduled where subjects undergo a limited 18F-FET PET/CT of the brain in SGH. After the study visit, from time of recruitment, they will continue their regular clinic visits as clinically indicated, where they will be monitored for at least a year for stability or deterioration. If clinically indicated, they may undergo conventional MRI, alternative MRI imaging and/or histopathological correlation in their respective primary institutions. During these follow-up visits, any adverse effects possibly attributed to the 18F-FET PET/CT can also be flagged up. Any alternative MRI imaging performed (as part of clinical practice in the respective primary institutions) within 4 weeks of the 18F-FET PET/CT study will also be included in the comparative analysis. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or Women, aged 21 years or older at time of screening
- Histologically confirmed diagnosis of malignant glioma (defined as WHO grade III or IV) with previous RT to tumour
- With enlarging contrast-enhancing and/or T2W/FLAIR-hyperintense lesion(s) on MRI within the previous RT field
- Gliomas with Isocitrate dehydrogenase (IDH) wild-type status, as defined on immunohistochemistry
- Subject must consent to undergo all study procedures
Key exclusion criteria (5 listed)
- Low-grade gliomas (histology grade 1 or 2 by WHO classification)16,17
- Previous bevacizumab or other vascular endothelial growth factor (VEGF) targeting agents or anti-angiogenic treatments.
- Proven cerebral metastases
- IDH-mutated gliomas
- Pregnancy/ breast-feeding
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 |
|---|---|---|
| FET PETThere is only one study visit during which study subjects will undergo a 18F-FET PET/CT in SGH. Following that, they will be followed up as per their routine clinical care. Data collection timepoints will be at 30 days, 4 months, 8 months and 1 year. | Diagnostic test | FET PET |
Primary outcome
Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging
Time frame: 1 year
Sensitivity and specificity of [18F]FET-PET in delineating disease.
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 3 Dec 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FET PET in people with Glioma, Malignant, run by Singapore General Hospital at 2 sites in Singapore.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging (time frame: 1 year). 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 3 Dec 2024.