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Completed

NCT Number: NCT06451042

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Difference in radiation treatment volume as determined by FET-PET/MRI compared to standard of care MRI.

    Time frame: 12 months

    Volume difference measured in cubic centimetres

Other outcomes

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

    Time frame: 12 months

    Volume difference measured in cubic centimetres

  2. Overall and recurrence-free survival post radiation treatment.

    Time frame: 12 months

    Measured in months

  3. Quality of life changes pre and post radiation treatment.

    Time frame: 12 months

    Units on a scale - Linear Analog Self-Assessment, score minimum = 0, score maximum = 10, higher is better

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Acronym: FET-TREAT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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