Children and adolescents with a primary brain tumour after first line therapy
Conditions
Interventions
Product Name: Fluoroethyltyrosin
Pharmaceutical Form: Radiopharmaceutical precursor, solution
INN or Proposed INN: Fluorethyltyrosin
CAS Number: 178433-03-9
Other descriptive name: Fluorethylthyrosin
Sponsors
Charité Universitaetsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 HIT-Netzwerk (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess sensitivity of FET PET in comparison with the sensitivity of MRI (? sensitivityFET PET to sensitivityMRT) To assess the positive and negative predictive value (PPV, NPV) of FET PET in comparison with the PPV and NPV of MRI (? NPVFET PET to NPVMRT) To evaluate specificity, sensitivity, PPV, and NPV by SUVratio analyses of FET PET data To evaluate the potential of FET PET for non-invasive tumour grading (WHO I/II vs. III/IV) by kinetic studies when histopathological results are available To assess adverse events and toxicity profile ;Primary end point(s): Specificity;Timepoint(s) of evaluation of this end point: at 12 or 24 months;Main Objective: The main objective is to evaluate the relative benefit of FET PET in comparison to the MRI in differentiating residual biologically active tumour tissue from therapy-related changes in paediatric brain tumours after first line therapy (? specificityFET PET to specificityMRT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Sensitivity, PPV, NPV, SUVratio, non-invasive tumour grading (WHO I/II vs. III/IV), adverse events, toxicity profile;Timepoint(s) of evaluation of this end point: at the timepoints of the trial visits (adverse events), or at the end of the trial; | — |
Countries
Germany
Contacts
Public ContactDepartment of Paediatric Oncology a
Charité - Universitätsmedizin Berlin
Outcome results
None listed