18F-FET PET/CT in the Management of Glioma

Not Applicable

Completed

• Conditions: Glioma
• Interventions: Device: 18F-FET PET/CT

• Registration Number: NCT06563024
• Lead Sponsor: Buddhist Tzu Chi General Hospital

Brief Summary

O-(2-\[18F\]-fluoroethyl)-L-tyrosine (FET) is a tracer for positron emission tomography (PET). The Response Assessment in Neuro-Oncology (RANO) working group has officially recommended 18F-FET PET in the management of patients with brain glioma. Recently, the utility of 18F-FET PET in the diagnosis of fresh and residual gliomas has been reported by several investigators. But clinical usefulness of radiomics parameters has not been explored thoroughly in glioma patients. 18F-FET PET has been widely used in clinical studies or routine service in Europe, America, Mainland China, or Japan. However, 18F-FET PET is still not available in Taiwan. In this context, the investigator propose this study to explore the role of multiparametric 18F-FET PET imaging for glioma in Taiwan, with the emphasis in radiomics analysis.

Detailed Description

Study background:

O-(2-\[18F\]-fluoroethyl)-L-tyrosine (FET) is a tracer for positron emission tomography (PET). The Response Assessment in Neuro-Oncology (RANO) working group has officially recommended 18F-FET PET in the management of patients with brain glioma. Recently, the utility of 18F-FET PET in the diagnosis of fresh and residual gliomas has been reported by several investigators. But clinical usefulness of radiomics parameters has not been explored thoroughly in glioma patients. 18F-FET PET has been widely used in clinical studies or routine service in Europe, America, Mainland China, or Japan. However, 18F-FET PET is still not available in Taiwan. In this context, the investigator propose this study to explore the role of multiparametric 18F-FET PET imaging for glioma in Taiwan.

Materials and methods:

1. During the pre-treatment work-up, the study participants undergo an 18F-FET PET/CT scan. In addition, other routine examinations, including MRI with and without contrast enhancement, are performed.

2. After a definitive diagnosis of primary/recurrent glioma is confirmed, subjects begin treatment (surgery, radiation therapy, chemotherapy, etc.). Within 3 to 6 months after completing treatment, the study subjects undergo a second 18F-FET PET/CT scan for response evaluation, along with a follow-up MRI.

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-08
• Study First Submitted: 2024-08-18
• Study First Submitted QC: 2024-08-18
• Last Update Submitted: 2024-08-18
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Patients with primary or recurrent brain tumors confirmed by pathological examination or imaging studies.
2. The ability to provide written informed consent and receive the scheduled scan.

Exclusion Criteria

1. Woman with pregnancy or during lactation.
2. Unsuitable for PET scans, such as those with claustrophobia or inability to lie flat.
3. Unable to sign the informed consent form.
4. Patients with a second primary tumor.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-FET PET	18F-FET PET/CT	The study participants receive the 18F-FET PET scan.

Primary Outcome Measures

Name	Time	Method
Overall survival	3 years	Overall survival is measured from the date of diagnosis to the date of death, or censored at last follow-up date.

Trial Locations

Locations (1)

Hualien Tzu Chi Hospital; 🇨🇳 Hualien City, Taiwan