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High Grade Glioma for Malignant Glioma (FETSMaRT Trial)

N/A
Waitlist Available
Led By Amit Singnurkar, MD, MBA
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* \>= 18 years of age
* High grade brain glioma (Grade 3 and 4)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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 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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of FET-PET imaging are not detailed here, but generally PET scans have minimal side effects, possibly including discomfort from lying still or reactions at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Observe recurrence/evaluate diagnostic performance of PET-FET/MRI vs MRI alone
Secondary study objectives
Analysis of PET Data
Evaluate recurrence
Evaluate tumor volume changes

Trial Design

1Treatment groups
Experimental Treatment
Group I: High Grade GliomaExperimental Treatment1 Intervention
0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) PET/MRI for planning of radiation therapy of post-operative grade III/IV glioma patients

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
671 Previous Clinical Trials
1,564,425 Total Patients Enrolled
Amit Singnurkar, MD, MBAPrincipal InvestigatorSunnybrook Healthcare Centre
~3 spots leftby Jan 2025