A new PET radiopharmaceutical in Hungary to detect brain tumors

Application of a new radioligand F-18 FET, and its clinical benefit in the diagnosis of primary and secondary brain tumors - -

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002948-14-HU

Enrollment

Registered

2015-09-24

Start date

2015-09-22

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Primary and secondary brain tumors

Interventions

Product Name: FET-PET oldatos injekció Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: histologically confirmed primary or secondary brain tumor previous MRI study (T1WI, PDWI, T2WI, postcontrast T1WI) clinical history is available cooperating patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: non-cooperating patient clinical data are not available claustrophobia patient refused participation pregnancy or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Clinical value of F-18 FET PET-CT in various types of brain tumor, compared to MRI;Secondary Objective: Quantitave F-18 FET PET-CT as a biomarker for the effectiveness of therapy, and for assessing prognosis;Primary end point(s): Accessing the clinical value of F-18 FET PET-CT in various types of brain tumor, compared to MRI.;Timepoint(s) of evaluation of this end point: Evaluation of this endpoint Dec. 20, 2016	—

Measure

Time frame

Main Objective: Clinical value of F-18 FET PET-CT in various types of brain tumor, compared to MRI;Secondary Objective: Quantitave F-18 FET PET-CT as a biomarker for the effectiveness of therapy, and for assessing prognosis;Primary end point(s): Accessing the clinical value of F-18 FET PET-CT in various types of brain tumor, compared to MRI.;Timepoint(s) of evaluation of this end point: Evaluation of this endpoint Dec. 20, 2016

—

Secondary

Measure	Time frame
Secondary end point(s): Testing the applicability of quantitave F-18 FET PET-CT as a biomarker for the effectiveness of therapy, and for estimating prognosis;Timepoint(s) of evaluation of this end point: Evaluation of this endpoint Dec. 20, 2016	—

Countries

Hungary

Contacts

Public ContactInnovation Director

PET Diagnosztikai Kft.

iherenyik@expintuitive-innovation.com36303974378

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026