TheranosticTrials.org

Clinical Trial · NCT04790097

FET-PET Directed Simultaneous In-field Boost for Primary GBM

Overview

The combination of anatomical MRI examination with functional examination of tissue metabolic activity such as FET-PET (PET using the radiotracer - 18F-fluoro-ethyl-tyrosine) is a valuable tool to determine the actual tumor infiltration. The FET-PET examination can be performed using the dual-time point aqusition of FET for exact treatment planning. It has also been proven that using the dual FET-PET method, it is possible to obtain a precise image of the glioblastoma infiltration corresponding to the location and shape of the recurrence, and the tumor volumes in dual FET-PET are significantly larger than in MRI. Moreover, tumor defined in dual FET-PET is different than that of the tumor defined in single FET-PET acquisition. In the DualFETboosT trial we plan to assess the safety and preliminary efficacy of hypofractionated irraditon using simultaneous in-field boost directed on dual FET-PET based tumor volumes for treatment of primary glioblastoma multiforme with concomitant temozolomide.

Sponsor

Unknown Organization

Phase

N/A

ClinicalTrials.gov

NCT04790097

Drug / Compound

O-(2-[18F]-fluoroethyl)-L-tyrosine

Isotope(s):
Target(s):
  • Amino Acid Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Liver enzyme parameters normal
  • Histopathological confirmation of glioblastoma (WHO grade IV)
  • General condition according to the Zubrod scale 0 or 2
  • The results of the parameters of the patient's functions are normal
  • The results of the blood counts are normal

Exclusion

  • Claustrophobia
  • Alcohol addiction
  • Prior brain radiation therapy
  • Pregnancy, lack of consent to the use of protection against pregnancy, puerperium
  • Coexistence of another cancer
  • Contraindications for MRI
  • No uptake visible in the FET-PET imaging
  • Contraindications to radiotherapy or chemotherapy
  • Mental illness
  • The location of the tumor in the area of the brain stem or cerebellum