NCT06563024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

3.4 years

First QC Date

August 18, 2024

Last Update Submit

August 18, 2024

Conditions

Keywords

Glioma, 18F-FET, PET

Outcome Measures

Primary Outcomes (1)

  • Overall survival

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

    3 years

Study Arms (1)

18F-FET PET

EXPERIMENTAL

The study participants receive the 18F-FET PET scan.

Device: 18F-FET PET/CT

Interventions

The enrolled patients receive the 18F-FET PET/CT.

18F-FET PET

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Location

Related Publications (1)

  • Chan SC, Chiu TL, Ng SH, Kao HW, Tsai ST, Liu SH. 18F-FET PET/CT can aid in diagnosing patients with indeterminate MRI findings for brain tumors: a prospective study. Ann Nucl Med. 2025 Apr;39(4):342-352. doi: 10.1007/s12149-024-02005-4. Epub 2024 Nov 26.

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Sheng-Chieh Chan

    Hualien Tzu Chi General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2024

First Posted

August 20, 2024

Study Start

August 1, 2020

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations