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Comparison of 18F-Fluciclovine PET versus 18F-Fluoroethyltyrosine PET in patients with newly diagnosed cerebral gliomas, recurrent cerebral gliomas and brain metastases – an open label single centre single arm prospective basket trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507786-26-00
Acronym
23-096
Enrollment
80
Registered
2024-03-11
Start date
2024-08-14
Completion date
Unknown
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with newly diagnosed cerebral gliomas, recurrent cerebral gliomas and brain metastases.

Brief summary

The primary endpoint is the agreement of the diagnosis of tumour size and tracer distribution in FET PET with FACBC PET in the examined patients based on consensus voting in the classification categories A or B by three examiners. Categories C and D will be assessed as disagreement.

Detailed description

Significant correlation of the tumour-to-brain ratios in FET and FACBC PET., Similar differences of Time-to-peak (TTP) and slope of the time-activity-curve (TAC) of FET and FACBC uptake in highgrade and low-grade gliomas., Similar accuracy of FET and FACBC PET in differentiating tumour progression (TP) and treatment related changes (TRC) in recurrent gliomas and brain metastases., Similar differences of TTP and slope of the TAC of FET and FACBC uptake in TP and TRC in recurrent gliomas and brain metastases.

Interventions

DRUGAxumin 3
DRUG200 MBq/mL solution for injection
DRUGFET

Sponsors

Universitaetsklinikum Aachen AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the agreement of the diagnosis of tumour size and tracer distribution in FET PET with FACBC PET in the examined patients based on consensus voting in the classification categories A or B by three examiners. Categories C and D will be assessed as disagreement.

Secondary

MeasureTime frame
Significant correlation of the tumour-to-brain ratios in FET and FACBC PET., Similar differences of Time-to-peak (TTP) and slope of the time-activity-curve (TAC) of FET and FACBC uptake in highgrade and low-grade gliomas., Similar accuracy of FET and FACBC PET in differentiating tumour progression (TP) and treatment related changes (TRC) in recurrent gliomas and brain metastases., Similar differences of TTP and slope of the TAC of FET and FACBC uptake in TP and TRC in recurrent gliomas and brain metastases.

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026