Glioma, MalignantFETSMaRTNCT06499831
18F-FET-PET/MRI vs Standard MRI Alone for Stereotactic RadioTherapy Planning for High Grade Brain Gliomas
A study testing 0-(2-18F-Fluoroethyl)-L-Tyrosine in people with Glioma, Malignant, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Amino acid PET imaging for brain gliomas is gaining acceptance for the diagnosis and monitoring of disease. This is commonly performed in Europe. There is an opportunity to develop this tracer for use in Ontario, specifically for accurate delineation of disease for therapy planning and for prediction of disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Malignant
- What is being tested?
- 0-(2-18F-Fluoroethyl)-L-Tyrosine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2021to 31 Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years of age
- High grade brain glioma (Grade 3 and 4)
- No prior radiation or systemic treatment for high grade glioma
- Planned to undergo radiation therapy with the following regimens:
- Grade 3: 54-60 Gy over 30 fractions with temozolomide
- Grade 3: 40Gy over 15 fractions with temozolomide
Show all 9Show fewer
- Grade 4: 60 Gy over 30 fractions, with or without temozolomide o Grade 4: 40 Gy over 15 fractions, with or without temozolomide
- Able to tolerate PET/MRI scan with intravenous contrast
- Willing to provide informed consent.
Who cannot join
- MRI contraindication
- Creatinine clearance < 30mL/min
- Inability to lie still for 40 minutes
- Gadolinium allergy
- Prior PET imaging
- 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
Official title: 18F-FET-PET/MRI Versus Standard MRI Alone for Stereotactic RadioTherapy Planning for High Grade Brain Gliomas: A Pilot Study
Amino acid PET imaging for brain gliomas is gaining acceptance for the diagnosis and monitoring of disease. This is commonly performed in Europe. There is an opportunity to develop this tracer for use in Ontario, specifically for accurate delineation of disease for therapy planning and for prediction of disease recurrence, which is difficult with conventional imaging and clinical assessment techniques. The goals of this project are to develop this tracer in our local setting for use in our patients, provide evidence in the Ontario setting of its utility in addressing these unmet needs, and provide pilot evidence for future clinical trials.
Gliomas are primary malignancies of the brain. The most aggressive and common form is glioblastoma multiforme (GBM), which accounts for more than 60% of all primary brain malignancies . The standard of care for patients with glioblastoma is maximally safe resection of the enhancing tumor regions and the necrotic core followed by radiotherapy with concurrent temozolomide. MRI is widely accepted as the method of choice for treatment planning and for following these patients to predict and to detect recurrent disease.
Read more
High grade gliomas 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, prediction and diagnosis of treatment failure remains a challenge. The result is frequent imaging mixed with uncertainty regarding the presence of viable tumor versus post-treatment effects. Furthermore, follow-up of these patients represents a high cost to the health system while symptom or disease control remains limited. A more accurate means identifying viable tumor is needed to guide management, reduce costs, and ultimately to improve patient survival and quality of life.
0-(2-18F-Fluoroethyl)-L-Tyrosine positron emission tomography (FET) is an amino acid agent derived from tyrosine that is able to cross the blood brain barrier. It has been studied primarily in diagnosis and detection of tumor recurrence in glioblastomas with emerging evidence for its use in brain metastases. Compared to conventional MRI, FET-PET has been shown to delineate geographically distinct tumor volume in newly diagnosed GBM suggesting the complementarity of the two modalities.
- Conditions
- Glioma, Malignant
- Being tested
- 0-(2-18F-Fluoroethyl)-L-Tyrosine
- Keywords
- FET-PET, PET, 0-(2-18F-Fluoroethyl)-L-Tyrosine, FET, Glioma, Glioblastoma
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0-(2-18F-Fluoroethyl)-L-TyrosineDiagnostic test
Also called FET
0-(2-18F-Fluoroethyl)-L-Tyrosine positron emission tomography (FET) is an amino acid agent derived from tyrosine that is able to cross the blood brain barrier. It has been studied primarily in diagnosis and detection of tumor recurrence in glioblastomas with emerging evidence for its use in brain metastases. Compared to conventional MRI, FET-PET has been shown to delineate geographically distinct tumor volume in newly diagnosed GBM suggesting the complementarity of the two modalities.
| Study group | Role | What they receive |
|---|---|---|
| High Grade Glioma | Experimental | 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) PET/MRI for planning of radiation therapy of post-operative grade III/IV glioma patients Receives: Diagnostic Test: 0-(2-18F-Fluoroethyl)-L-Tyrosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observe recurrence/evaluate diagnostic performance of PET-FET/MRI vs MRI alone
To estimate the rate of change in management due to 18F-FET-PET/MRI when used in addition to standard of care MRI.
Measured: 12 Months
Secondary outcomes (3)
Evaluate tumor volume changes
Evaluate differences in total tumor volume as defined by 18F-FET-PET versus MRI pre-operatively
Measured: 12 Months
Evaluate recurrence
Evaluate diagnostic performance of FET-PET/MRI versus MRI alone for predicting recurrence at 12 months.
Measured: 12 Months
Analysis of PET Data
Develop and test new MRI and PET analyses to improve recurrence prediction using machine learning and conventional statistical models
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 posted15 Jul 2024
- Study start15 Dec 2021
- Primary completion31 Jan 2025
- Study completion31 Jan 2026 (estimated)
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 Glioma, MalignantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will assess differences in management based on standard of care MRI versus intended care based on FET-PET-MRI. Changes in management will be recorded as a simulation but patients will still receive routine standard of care.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Singnurkar, MD, MBA, Principal investigator, Sunnybrook Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499831
- Sponsor's protocol ID
- 3728
- Acronym
- FETSMaRT
- Status last verified
- Jun 2024
- First submitted
- 26 Jul 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singnurkar A, Sahgal A, Lechtman E, Lim-Fat MJ, Graham SJ, Lipsman N, Maralani P, Pond G, Detsky JS. Volumetric discordance between (1)(8)F-FET-PET/MRI and MRI-based radiotherapy target volumes in high-grade glioma: a prospective pilot study (FETSMaRT). J Neurooncol. 2026 Oct 14;180(1):20. doi: 10.1007/s11060-026-05831-w.
PubMed 42875659
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FET-PET/MRI Versus Standard MRI Alone for Stereotactic RadioTherapy Planning for High Grade Brain Gliomas: A Pilot Study
- ClinicalTrials.gov ID
- NCT06499831
- Acronym / sponsor ID
- FETSMaRT / 3728
- Conditions
- Glioma, Malignant
- Keywords
- FET-PET, PET, 0-(2-18F-Fluoroethyl)-L-Tyrosine, FET, Glioma, Glioblastoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 15 Jul 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.
Amino acid PET imaging for brain gliomas is gaining acceptance for the diagnosis and monitoring of disease. This is commonly performed in Europe. There is an opportunity to develop this tracer for use in Ontario, specifically for accurate delineation of disease for therapy planning and for prediction of disease recurrence, which is difficult with conventional imaging and clinical assessment techniques. The goals of this project are to develop this tracer in our local setting for use in our patients, provide evidence in the Ontario setting of its utility in addressing these unmet needs, and provide pilot evidence for future clinical trials.
Gliomas are primary malignancies of the brain. The most aggressive and common form is glioblastoma multiforme (GBM), which accounts for more than 60% of all primary brain malignancies . The standard of care for patients with glioblastoma is maximally safe resection of the enhancing tumor regions and the necrotic core followed by radiotherapy with concurrent temozolomide. MRI is widely accepted as the method of choice for treatment planning and for following these patients to predict and to detect recurrent disease.
High grade gliomas 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, prediction and diagnosis of treatment failure remains a challenge. The result is frequent imaging mixed with uncertainty regarding the presence of viable tumor versus post-treatment effects. Furthermore, follow-up of these patients represents a high cost to the health system while symptom or disease control remains limited. A more accurate means identifying viable tumor is needed to guide management, reduce costs, and ultimately to improve patient survival and quality of life.
0-(2-18F-Fluoroethyl)-L-Tyrosine positron emission tomography (FET) is an amino acid agent derived from tyrosine that is able to cross the blood brain barrier. It has been studied primarily in diagnosis and detection of tumor recurrence in glioblastomas with emerging evidence for its use in brain metastases. Compared to conventional MRI, FET-PET has been shown to delineate geographically distinct tumor volume in newly diagnosed GBM suggesting the complementarity of the two modalities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will assess differences in management based on standard of care MRI versus intended care based on FET-PET-MRI. Changes in management will be recorded as a simulation but patients will still receive routine standard of care.
| Arm | Type | Receives |
|---|---|---|
| High Grade Glioma | Experimental | Diagnostic Test: 0-(2-18F-Fluoroethyl)-L-Tyrosine0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) PET/MRI for planning of radiation therapy of post-operative grade III/IV glioma patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- >= 18 years of age
- High grade brain glioma (Grade 3 and 4)
- No prior radiation or systemic treatment for high grade glioma
- Planned to undergo radiation therapy with the following regimens:
- Able to tolerate PET/MRI scan with intravenous contrast
Key exclusion criteria (8 listed)
- MRI contraindication
- Creatinine clearance < 30mL/min
- Inability to lie still for 40 minutes
- Gadolinium allergy
- Prior PET imaging
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 |
|---|---|---|
| 0-(2-18F-Fluoroethyl)-L-TyrosineAlso: FET0-(2-18F-Fluoroethyl)-L-Tyrosine positron emission tomography (FET) is an amino acid agent derived from tyrosine that is able to cross the blood brain barrier. It has been studied primarily in diagnosis and detection of tumor recurrence in glioblastomas with emerging evidence for its use in brain metastases. Compared to conventional MRI, FET-PET has been shown to delineate geographically distinct tumor volume in newly diagnosed GBM suggesting the complementarity of the two modalities. | Diagnostic test | High Grade Glioma |
Primary outcome
Observe recurrence/evaluate diagnostic performance of PET-FET/MRI vs MRI alone
Time frame: 12 Months
To estimate the rate of change in management due to 18F-FET-PET/MRI when used in addition to standard of care MRI.
3 secondary outcomes
Evaluate tumor volume changes
Time frame: 12 Months
Evaluate recurrence
Time frame: 12 Months
Analysis of PET Data
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 42875659Singnurkar A, Sahgal A, Lechtman E, Lim-Fat MJ, Graham SJ, Lipsman N, Maralani P, Pond G, Detsky JS. Volumetric discordance between (1)(8)F-FET-PET/MRI and MRI-based radiotherapy target volumes in high-grade glioma: a prospective pilot study (FETSMaRT). J Neurooncol. 2026 Oct 14;180(1):20. doi: 10.1007/s11060-026-05831-w.
- 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, MD, MBA principal investigator
Sunnybrook Healthcare Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0-(2-18F-Fluoroethyl)-L-Tyrosine in people with Glioma, Malignant, 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 9 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: status not confirmed, as of the sponsor's last update on 25 May 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?
Results are not available in the source record.
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?
Observe recurrence/evaluate diagnostic performance of PET-FET/MRI vs MRI alone (time frame: 12 Months). 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 NCT06499831, 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 25 May 2025.