FET-PET/MRI for Brain Tumors

(FETSMaRT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: Temozolomide

Disqualifiers: MRI contraindication, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique that could improve diagnosis and treatment planning for individuals with high-grade brain tumors, such as glioblastoma. The researchers aim to test a special amino acid PET scan, known as FET-PET, which uses 0-(2-18F-Fluoroethyl)-L-Tyrosine and may reveal tumor details more effectively than standard MRI scans. This could assist doctors in planning more effective treatments and predicting tumor recurrence. Individuals who have not yet undergone radiation or chemotherapy and are about to begin radiation treatment may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment strategies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging technique is safe for use in brain tumor patients?

Research has shown that 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) is generally safe for patients with high-grade gliomas, aggressive brain tumors. Studies have examined FET's safety and found no major concerns for patients using this imaging agent. This tracer enhances tumor visibility and is already used in Europe for diagnosing and monitoring these brain tumors.

Although specific safety details are not provided, FET's use in Europe suggests it is safe for similar applications elsewhere. Prospective trial participants can find reassurance in its established use without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) PET/MRI for brain tumors because it offers a new way to plan radiation therapy for patients with high-grade gliomas. Unlike traditional imaging methods, FET-PET/MRI provides more precise imaging of tumor activity, which can help tailor radiation treatments more effectively. This advanced imaging technique could lead to better targeting of tumors, potentially sparing healthy brain tissue and improving patient outcomes.

What evidence suggests that FET-PET/MRI is effective for brain tumors?

Research has shown that a special type of scan called FET PET is a promising tool for managing gliomas, which are brain tumors. Studies have found that FET PET can more accurately show the tumor's location and help determine if it has returned after treatment, compared to using an MRI alone. This trial tests the effectiveness of combining FET PET with MRI in planning radiation therapy for post-operative grade III/IV glioma patients. This combination also makes it easier to detect tumor tissue, aiding in treatment planning. This imaging method is gaining acceptance in Europe and is now being tested in Ontario to better guide therapy and predict disease recurrence. ^{3 6 7 8 9}

Who Is on the Research Team?

Amit Singnurkar, MD, MBA

Principal Investigator

Sunnybrook Healthcare Centre

Are You a Good Fit for This Trial?

This trial is for patients with high-grade brain gliomas, specifically those who are likely to benefit from precise therapy planning. It's not clear who can't participate since the exclusion criteria aren't provided.

Inclusion Criteria

I haven't had radiation or systemic treatment for my high grade brain tumor.

My brain tumor is high grade (Grade 3 or 4).

Willing to provide informed consent

Exclusion Criteria

MRI contraindication

My kidney function is severely reduced.

Gadolinium allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) PET/MRI for planning of radiation therapy

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• 0-(2-18F-Fluoroethyl)-L-Tyrosine

Trial Overview The study is testing if a PET imaging agent called 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) can better identify tumor boundaries in the brain compared to standard MRI, which could improve treatment planning and monitoring.

How Is the Trial Designed?

Group I: High Grade Glioma Experimental Treatment 1 Intervention

0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) PET/MRI for planning of radiation therapy of post-operative grade III/IV glioma patients

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11435125/

Contribution of [18F]FET PET in the Management of Gliomas ... Our findings confirm that [ 18 F]FET helps delineate tumor tissue, improves diagnostic accuracy, and aids in therapeutic decision-making.

2. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/799540

Evaluation of O-(2-[18F]-Fluoroethyl)-L-Tyrosine in the ... Conclusion The initial results are promising and indicate that FET PET is a valuable and applicable tool for the imaging of high-grade glioma.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06499831?intr=L-TYROSINE&aggFilters=studyType:int&viewType=Table&rank=9

18F-FET-PET/​MRI vs Standard MRI Alone for Stereotactic ... 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 ...

4. academic.oup.com academic.oup.com/brain/article/128/3/678/693026

O-(2-[18F]fluoroethyl)-l-tyrosine PET combined with MRI ... MRI yielded a sensitivity of 96% for the detection of tumour tissue but a specificity of only 53%, and combined use of MRI and FET PET yielded a sensitivity of ...

5. nature.com nature.com/articles/s41598-025-90472-8

An effective MRI perfusion threshold based workflow to ... We propose a sequential, threshold-based workflow to triage patients for additional 18 F-FET PET scans based on MRI dynamic susceptibility contrast (DSC) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8666958/

Glioma Imaging by O-(2-18F-Fluoroethyl)-L-Tyrosine PET ... Grade II glioma was defined as low-grade glioma (LGG) and grade III-IV glioma was defined as high-grade glioma (HGG). Grade I glioma was not included in ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/48/4/519

Prognostic Value of O-(2-18F-Fluoroethyl)-l-Tyrosine PET and ... Statistical endpoints were clinical or radiologic tumor progression, malignant transformation to glioma of WHO grade III or IV (high-grade glioma), and death.

8. academic.oup.com academic.oup.com/neuro-oncology/article/19/5/710/2760195

use of O-(2-18F-fluoroethyl)-L-tyrosine PET in the diagnosis of ... All high-grade gliomas of WHO grade III (n = 2) (Fig. 1) and WHO grade IV (n = 1) as well as 5 of 11 low-grade gliomas exhibited a TBRmax ...

9. nature.com nature.com/articles/s41598-018-25350-7

Impact of 18 F-FET PET on Target Volume Definition and ... The prognosis of patients diagnosed with HGG remains poor, with median overall survival times of 10–15 months in grade IV glioma (glioblastoma ...