NCT06172595

Brief Summary

The goal of this clinical trial is to evaluate the performance characteristics of O-(2-\[18F\]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of \[18F\]FET-PET in delineating disease. The main question\[s\] it aims to answer are:

  • whether 18F-FET-PET will demonstrate high diagnostic accuracy to detect true tumour progression
  • whether we can optimise the threshold cut-offs for TBRmax and other relevant parameters in discriminating pseudoprogression and disease progression Participants will undergo a limited 18F-FET PET/CT of the brain in SGH.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

December 21, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

December 7, 2023

Last Update Submit

November 28, 2024

Conditions

Glioma, Malignant

Outcome Measures

Primary Outcomes (1)

  • Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging

    Sensitivity and specificity of \[18F\]FET-PET in delineating disease.

    1 year

Study Arms (1)

FET PET

EXPERIMENTAL

Upon recruitment, a single study visit will be scheduled where subjects undergo a limited 18F-FET PET/CT of the brain in SGH. After the study visit, from time of recruitment, they will continue their regular clinic visits as clinically indicated, where they will be monitored for at least a year for stability or deterioration. If clinically indicated, they may undergo conventional MRI, alternative MRI imaging and/or histopathological correlation in their respective primary institutions. During these follow-up visits, any adverse effects possibly attributed to the 18F-FET PET/CT can also be flagged up. Any alternative MRI imaging performed (as part of clinical practice in the respective primary institutions) within 4 weeks of the 18F-FET PET/CT study will also be included in the comparative analysis.

Diagnostic Test: FET PET

Interventions

FET PETDIAGNOSTIC_TEST

There is only one study visit during which study subjects will undergo a 18F-FET PET/CT in SGH. Following that, they will be followed up as per their routine clinical care. Data collection timepoints will be at 30 days, 4 months, 8 months and 1 year.

FET PET

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or Women, aged 21 years or older at time of screening
  • Histologically confirmed diagnosis of malignant glioma (defined as WHO grade III or IV) with previous RT to tumour
  • With enlarging contrast-enhancing and/or T2W/FLAIR-hyperintense lesion(s) on MRI within the previous RT field
  • Gliomas with Isocitrate dehydrogenase (IDH) wild-type status, as defined on immunohistochemistry
  • Subject must consent to undergo all study procedures

You may not qualify if:

  • Low-grade gliomas (histology grade 1 or 2 by WHO classification)16,17
  • Previous bevacizumab or other vascular endothelial growth factor (VEGF) targeting agents or anti-angiogenic treatments.
  • Proven cerebral metastases
  • IDH-mutated gliomas
  • Pregnancy/ breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Centre Singapore

Singapore, Singapore

RECRUITING

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 15, 2023

Study Start

December 21, 2023

Primary Completion

December 31, 2025

Study Completion

February 28, 2026

Last Updated

December 3, 2024

Record last verified: 2024-11

Locations

SG(2)