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Clinical Trials/NCT06563024
NCT06563024
Completed
Not Applicable

Prospective Investigation in the Utility of Multiparametric 18F-FET PET/CT in the Management of Glioma: Application of PET Radiomics

Buddhist Tzu Chi General Hospital1 site in 1 country36 target enrollmentAugust 1, 2020
ConditionsGlioma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glioma
Sponsor
Buddhist Tzu Chi General Hospital
Enrollment
36
Locations
1
Primary Endpoint
Overall survival
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
December 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Buddhist Tzu Chi General Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Overall survival

Time Frame: 3 years

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

Study Sites (1)

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