18F-FET PET in Childhood Brain Tumours

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 160
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Last Updated: 2017-07-10

Criteria

Inclusion Criteria:

• Written informed consent (given by the parents as legal representatives of the patients and given by the patients)

• Completion of the first line therapy according to the current HIT-protocols (Current and subsequent paediatric primary brain tumour treatment studies approved by GPOH)

• Fully evaluable MRI at the end of first line therapy as confirmed by the reference centre of neuroradiology (Prof. Dr. M. Warmuth-Metz, Würzburg)

• 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

• Age at inclusion: 1 year to 17 years

• Children below the age of 12 years are included as 2 of 3 paediatric patients with a brain tumour are younger than 12 years. Furthermore, young age is a known negative risk factor for different histological entities. Thus, this group is the most likely to benefit from the results of this study

• In all patients with reproductive potential, a pregnancy must be excluded by a pregnancy test before FET PET investigation

• Highly effective contraception in women with reproductive potential (defined as pearl index < 1) during study participation and follow up time

• No participation in other clinical trials according to AMG with the same clinical indication over the course of the FET PET 2010 study

Exclusion Criteria:

• 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);

• Known allergic reactions or drug intolerance to contrast agents

• Patients according to § 88 StrhlSchV

• Pregnancy or breast-feeding

• Women (adolescents) of childbearing potential without highly effective contraception (PEARL-Index < 1%), for example ParaGard IntraUterineDevice (IUD), Mirena IUD, Implants, Depo Provera Injections;

• Persons who are detained officially or legally to an official institute