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

Recruiting

• Conditions: Glioblastoma Multiforme
• Interventions: Diagnostic Test: FET-PET/MRI

• Registration Number: NCT06451042
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-10
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-28
• Study Start: 2024-07-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Operative GBM Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI)	FET-PET/MRI	0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) PET/MRI for planning of radiation therapy of post-operative glioblastoma multiforme patients

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada