TheranosticTrials.org

Clinical Trial · NCT03216148

18F-FET PET in Childhood Brain Tumours

Overview

FET PET 2010 is a prospective, multicentre trial aiming to evaluate the additional benefit of FET PET in the assessment of remission after first line therapy and during follow-up

Sponsor

Charite University, Berlin, Germany

Phase

Phase 2

Contacts

Michail Plotkin, MD (STUDY_CHAIR)

Pablo Hernáiz Driever, MD (PRINCIPAL_INVESTIGATOR)

Ramona Stöckl (CONTACT)

ramona.stoeckl@charite.de

Uwe Behrens, PhD (CONTACT)

uwe.behrens@charite.de

ClinicalTrials.gov

NCT03216148

Drug / Compound

FET

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

Eligibility

Inclusion

  • Completion of the first line therapy according to the current HIT-protocols (Current and subsequent paediatric primary brain tumour treatment studies approved by GPOH)
  • Histology of primary brain tumour confirmed by local and reference centre of Neuropathology (Prof. Dr. T. Pietsch) except for patients where tumour diagnosis is confirmed by the reference centre of neuroradiology, i.e. NF-1 and confirmed LGG or patient with diffuse intrinsic pontine glioma
  • Laboratory requirements prior to enrolment: Serum creatinine: within normal limits; AST, ALT: not more than 10 x above normal limits
  • Highly effective contraception in women with reproductive potential (defined as pearl index \< 1) during study participation and follow up time

Exclusion

  • Presence of solid non-CNS tumours or leukaemia
  • MRI at completion of first line therapy that does not meet standard quality criteria for evaluation as defined by the reference centre for neuroradiology of the HITNetzwerk (Würzburg, Prof. Warmuth-Metz);