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

NCT06451042 | Completed DMC

• 1 other identifier: 5919
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma Multiforme

Keywords

FET-PET; Glioblastoma; GBM; 0-(2-18F-Fluoroethyl)-L-Tyrosine (FET); Glioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Difference in pre- and post-treatment metabolic tumor volume as determined by FET-PET.

  12 months

• Overall and recurrence-free survival post radiation treatment.

  12 months

• Quality of life changes pre and post radiation treatment.

  12 months

Study Arms (1)

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

Interventions

FET-PET/MRI DIAGNOSTIC_TEST

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.

Post-Operative GBM Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Amit Singnurkar

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 10, 2024
• Study Start: July 1, 2024
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)