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

NCT ID: NCT06451042

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-12-08

Brief Summary

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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

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Conditions

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Glioblastoma Multiforme

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

FET-PET/MRI

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* ≥ 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amit Singnurkar

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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5919

Identifier Type: -

Identifier Source: org_study_id