FET-PET/MRI Based Treatment Planning for Glioblastoma Multiforme in Post-Surgical Patients (FET-TREAT) (FET-TREAT)

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 Overview

• Status: Completed
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Diagnostic test: FET-PET/MRI

Detailed Description

Please see trial details below:

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: FET-PET/MRI; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in radiation treatment volume as determined by FET-PET/MRI compared to standard of care MRI.	Volume difference measured in cubic centimetres	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in pre- and post-treatment metabolic tumor volume as determined by FET-PET.	Volume difference measured in cubic centimetres	12 months
Overall and recurrence-free survival post radiation treatment.	Measured in months	12 months
Quality of life changes pre and post radiation treatment.	Units on a scale - Linear Analog Self-Assessment, score minimum = 0, score maximum = 10, higher is better	12 months

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Amit Singnurkar, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): December 8, 2025
• Study Completion (Actual): December 8, 2025

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Glioma; GBM; Glioblastoma; FET-PET; 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET)
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma
• Other Study ID Numbers: 5919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No