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

Glioblastoma Multiforme Clinical Trial

— FET-TREAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451042
• Other study ID #: 5919
• Status: Recruiting
• Start date: July 1, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: May 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: Amit Singnurkar, MD
• Phone: 416-480-6100
• Email: amit.singnurkar[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Please see trial details below:

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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 MBq administered intravenously prior to PET/MRI imaging.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in pre- and post-treatment metabolic tumor volume as determined by FET-PET.	Volume difference measured in cubic centimetres	12 months
Other	Overall and recurrence-free survival post radiation treatment.	Measured in months	12 months
Other	Quality of life changes pre and post radiation treatment.	Units on a scale	12 months
Primary	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