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

August 18, 2024 updated by: Buddhist Tzu Chi General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hualien City, Taiwan
        • Hualien Tzu Chi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-FET PET
The study participants receive the 18F-FET PET scan.
Device: 18F-FET PET/CT
The enrolled patients receive the 18F-FET PET/CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Buddhist Tzu Chi General Hospital

Investigators

  • Study Director: Sheng-Chieh Chan, Hualien Tzu Chi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

August 18, 2024

First Submitted That Met QC Criteria

August 18, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 18, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB108-262-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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