18F-FET-PET/MRI vs Standard MRI Alone for Stereotactic RadioTherapy Planning for High Grade Brain Gliomas

NCT06499831 | Active Not Recruiting DMC

• 1 other identifier: 3728
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Amino acid PET imaging for brain gliomas is gaining acceptance for the diagnosis and monitoring of disease. This is commonly performed in Europe. There is an opportunity to develop this tracer for use in Ontario, specifically for accurate delineation of disease for therapy planning and for prediction of disease recurrence, which is difficult with conventional imaging and clinical assessment techniques. The goals of this project are to develop this tracer in our local setting for use in our patients, provide evidence in the Ontario setting of its utility in addressing these unmet needs, and provide pilot evidence for future clinical trials. Gliomas are primary malignancies of the brain. The most aggressive and common form is glioblastoma multiforme (GBM), which accounts for more than 60% of all primary brain malignancies . The standard of care for patients with glioblastoma is maximally safe resection of the enhancing tumor regions and the necrotic core followed by radiotherapy with concurrent temozolomide. MRI is widely accepted as the method of choice for treatment planning and for following these patients to predict and to detect recurrent disease. High grade gliomas 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, prediction and diagnosis of treatment failure remains a challenge. The result is frequent imaging mixed with uncertainty regarding the presence of viable tumor versus post-treatment effects. Furthermore, follow-up of these patients represents a high cost to the health system while symptom or disease control remains limited. A more accurate means identifying viable tumor is needed to guide management, reduce costs, and ultimately to improve patient survival and quality of life. 0-(2-18F-Fluoroethyl)-L-Tyrosine positron emission tomography (FET) is an amino acid agent derived from tyrosine that is able to cross the blood brain barrier. It has been studied primarily in diagnosis and detection of tumor recurrence in glioblastomas with emerging evidence for its use in brain metastases. Compared to conventional MRI, FET-PET has been shown to delineate geographically distinct tumor volume in newly diagnosed GBM suggesting the complementarity of the two modalities.

Conditions

Glioma, Malignant

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Observe recurrence/evaluate diagnostic performance of PET-FET/MRI vs MRI alone

  To estimate the rate of change in management due to 18F-FET-PET/MRI when used in addition to standard of care MRI.

  12 Months

Secondary Outcomes (3)

• Evaluate tumor volume changes

  12 Months

• Evaluate recurrence

  12 Months

• Analysis of PET Data

  12 Months

Study Arms (1)

High Grade Glioma

EXPERIMENTAL

0-(2-18F-Fluoroethyl)-L-Tyrosine (FET) PET/MRI for planning of radiation therapy of post-operative grade III/IV glioma patients

Diagnostic Test: 0-(2-18F-Fluoroethyl)-L-Tyrosine

Interventions

0-(2-18F-Fluoroethyl)-L-Tyrosine DIAGNOSTIC_TEST

0-(2-18F-Fluoroethyl)-L-Tyrosine positron emission tomography (FET) is an amino acid agent derived from tyrosine that is able to cross the blood brain barrier. It has been studied primarily in diagnosis and detection of tumor recurrence in glioblastomas with emerging evidence for its use in brain metastases. Compared to conventional MRI, FET-PET has been shown to delineate geographically distinct tumor volume in newly diagnosed GBM suggesting the complementarity of the two modalities.

Also known as: FET

High Grade Glioma

Eligibility Criteria

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

You may qualify if:

• \>= 18 years of age
• High grade brain glioma (Grade 3 and 4)
• No prior radiation or systemic treatment for high grade glioma
• Planned to undergo radiation therapy with the following regimens:
• Grade 3: 54-60 Gy over 30 fractions with temozolomide
• Grade 3: 40Gy over 15 fractions with temozolomide
• Grade 4: 60 Gy over 30 fractions, with or without temozolomide o Grade 4: 40 Gy over 15 fractions, with or without temozolomide
• 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 40 minutes
• Gadolinium allergy
• Prior PET imaging
• 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, M4N2M5, Canada

Location

MeSH Terms

Conditions

Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Amit Singnurkar, MD, MBA

  Sunnybrook Healthcare Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The radiation oncologist is blinded to result from FET-FET/MRI while planning on standard fo care MRI.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will assess differences in management based on standard of care MRI versus intended care based on FET-PET-MRI. Changes in management will be recorded as a simulation but patients will still receive routine standard of care.

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 15, 2024
• Study Start: December 15, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2026
• Last Updated: May 25, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)