Clinical trial · Interventional
18F-FET PET in Childhood Brain Tumours
A Prospective, Multicentre Trial on the Value of 18F-FET PET in the Post-therapeutic Evaluation of Childhood Brain Tumours
NCT03216148CI-TRIAL-00028715unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasm | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FET-PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FET-PET
- description
- All participating patients will receive a FET PET-scan with intravenous O-(2-\[18F\]Fluoroethyl)-L-Tyrosine parallel to the routine MRI at the end of the first line therapy (restaging) according to the HIT-protocol Second FET PET: In case of suspected tumour recurrence or progression within the follow-up period of 24 (12) months, the participating patient will receive a second FET PET-scan (parallel to an MRI)
- interventionNames
- Diagnostic Test: FET-PET
Primary outcomes (1)
- measure
- Differentiating biologically active Tumor tissue from therapy related changes by using MRI (Magnetic Resonance Imaging) and FET PET
- timeFrame
- 3 years
- description
- 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 (Δ specificityFET PET to specificityMRT)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.