TheranosticTrials.org

Clinical Trial · NCT02025231

Image Guided Reirradiation of High-grade Glioma

Overview

The purpose of the study is to evaluate the short- and long term toxicity of radiotherapy to patients with recurrent high-grade glioma who have previously received radiotherapy and to determine the best dose and treatment regimen. Positron emission tomography (PET) using an amino acid tracer, 18-fluoro-ethyltyrosine (18F-FET), is used for target delineation.The study examines, in four sequential treatment groups, the effect of dose, hypofractionation and treatment volume on toxicity. Upon completion of the phase I part, the study progresses to phase II where the best dose- and treatment regimen will be chosen for treatment.

Sponsor

National University Hospital, Singapore

Phase

Phase 1/2

Contacts

Svend Aage Engelholm, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT02025231

Drug / Compound

FET

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

Eligibility

Inclusion

  • ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 or 2
  • able to understand oral and written Danish
  • no standard treatment options available/indicated
  • recurrent high-grade glioma
  • life expectancy \> 3 months
  • previous focal radiotherapy for high-grade glioma
  • hemoglobin value \> 6 mmol/l (transfusion permitted)

Exclusion

  • other previous radiotherapy to the brain than primary course of irradiation
  • infection or wound dehiscence or other pathological condition in meninges/skull/scalp
  • contraindications to magnetic resonance imaging (MRI) or positron emission tomography (PET)
  • symptoms of elevated intracranial pressure
  • disseminated recurrent disease
  • very early recurrence following primary radiotherapy (\< or equal to 3 months)