Glioblastoma MultiformeFET-TREATNCT06451042
FET-PET/MRI Based Treatment Planning for Glioblastoma Multiforme in Post-Surgical Patients (FET-TREAT)
An observational study of Glioblastoma Multiforme, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Glioblastoma multiforme (GBM) represent the most common primary brain malignancy and prognosis remains poor. The most common subtype is glioblastoma which has a 5-year survival rate of approximately 5%. Despite advances in MRI techniques, accurately determining total extent of tumor remains a challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- FET-PET/MRI
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2024to 8 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of both males and females over 18 years of age post maximally safe resection of glioblastoma multiforme and intent to treat with stereotactic radiation.
Who may be able to join
- Each participant must meet all of the following inclusion criteria to participate in this study:
- ≥ 18 years of age
- Diagnosis of glioblastoma multiforme
- Post-maximally safe surgical resection
- No prior radiation or systemic treatment for high grade glioma
- Able to tolerate PET/MRI scan with intravenous contrast
- Willing to provide informed consent
Who cannot join
- All participants meeting any of the following exclusion criteria at baseline screening will be excluded from participation in this study:
- MRI contraindication
- Creatinine clearance < 30mL/min
- Inability to lie still for 60 minutes
- Gadolinium allergy
- Positive pregnancy test
- Breastfeeding
- Patient unable to follow the protocol for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Glioblastoma multiforme (GBM) represent the most common primary brain malignancy and prognosis remains poor. The most common subtype is glioblastoma which has a 5-year survival rate of approximately 5%. Despite advances in MRI techniques, accurately determining total extent of tumor remains a challenge. The result is incomplete treatment resulting in reduced survival or overtreatment resulting in avoidable treatment related morbidity. A more accurate means of assessing tumor extent is needed to guide management to improve patient survival and quality of life.
- Conditions
- Glioblastoma Multiforme
- Being tested
- FET-PET/MRI
- Keywords
- FET-PET, Glioblastoma, GBM, 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET), Glioma
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FET-PET/MRIDiagnostic test
Radiation planning target volume (PTV) when planned with FET-PET/MRI to PTV when planned with conventional (Standard of Care) MRI only. 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) 180-200 megabecquerel (MBq) administered intravenously prior to PET/MRI imaging.
| Study group | Role | What they receive |
|---|---|---|
| Post-Operative GBM Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) | 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) PET/MRI for planning of radiation therapy of post-operative glioblastoma multiforme patients Receives: Diagnostic Test: FET-PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in radiation treatment volume as determined by FET-PET/MRI compared to standard of care MRI.
Volume difference measured in cubic centimetres
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jul 2024
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Singnurkar, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451042
- Sponsor's protocol ID
- 5919
- Acronym
- FET-TREAT
- Status last verified
- Dec 2025
- First submitted
- 31 May 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FET-PET/MRI Based Treatment Planning for Glioblastoma Multiforme in Post-Surgical Patients (FET-TREAT)
- ClinicalTrials.gov ID
- NCT06451042
- Acronym / sponsor ID
- FET-TREAT / 5919
- Conditions
- Glioblastoma Multiforme
- Keywords
- FET-PET, Glioblastoma, GBM, 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET), Glioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 10 Jun 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.
Glioblastoma multiforme (GBM) represent the most common primary brain malignancy and prognosis remains poor. The most common subtype is glioblastoma which has a 5-year survival rate of approximately 5%. Despite advances in MRI techniques, accurately determining total extent of tumor remains a challenge. The result is incomplete treatment resulting in reduced survival or overtreatment resulting in avoidable treatment related morbidity. A more accurate means of assessing tumor extent is needed to guide management to improve patient survival and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Operative GBM Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) | – | Diagnostic Test: FET-PET/MRI0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) PET/MRI for planning of radiation therapy of post-operative glioblastoma multiforme patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of both males and females over 18 years of age post maximally safe resection of glioblastoma multiforme and intent to treat with stereotactic radiation.
Key inclusion criteria (7 listed)
- Each participant must meet all of the following inclusion criteria to participate in this study:
- ≥ 18 years of age
- Diagnosis of glioblastoma multiforme
- Post-maximally safe surgical resection
- No prior radiation or systemic treatment for high grade glioma
Key exclusion criteria (8 listed)
- All participants meeting any of the following exclusion criteria at baseline screening will be excluded from participation in this study:
- MRI contraindication
- Creatinine clearance < 30mL/min
- Inability to lie still for 60 minutes
- Gadolinium allergy
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-PET/MRIRadiation planning target volume (PTV) when planned with FET-PET/MRI to PTV when planned with conventional (Standard of Care) MRI only. 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) 180-200 megabecquerel (MBq) administered intravenously prior to PET/MRI imaging. | Diagnostic test | Post-Operative GBM Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) |
Primary outcome
Difference in radiation treatment volume as determined by FET-PET/MRI compared to standard of care MRI.
Time frame: 12 months
Volume difference measured in cubic centimetres
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 18 Dec 2025.
- 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.
Amit Singnurkar principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma Multiforme, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 7 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: finished, as of the sponsor's last update on 18 Dec 2025. 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 Canada. 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?
Difference in radiation treatment volume as determined by FET-PET/MRI compared to standard of care MRI. (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 18 Dec 2025.