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
2 other identifiers
interventional
160
1 country
22
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2015
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 10, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJuly 21, 2017
July 1, 2017
3 years
July 10, 2017
July 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differentiating biologically active Tumor tissue from therapy related changes by using MRI (Magnetic Resonance Imaging) and FET PET
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)
3 years
Secondary Outcomes (4)
Sensitivity of FET-PET when differentiating biologically active Tumor tissue from therapy-related changes by using MRI (Magnetic Resonance Imaging) and FET PET
3 years
Assessment of the predictive value of FET-PET when differentiating biologically active Tumor tissue from therapy-related changes by using MRI (Magnetic Resonance Imaging) and FET PET
4 years
Assessment of Tumor grading by FET-PET when differentiating biologically active Tumor tissue from therapy-related changes by using MRI (Magnetic Resonance Imaging) and FET PET
4 years
Safety data on FET-PET in children with brain tumors
3 years
Study Arms (1)
FET-PET
EXPERIMENTALAll 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)
Interventions
All participating patients will receive a FET PET-scan 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)
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Klinikum Augsburg, Onkologie
Augsburg, 86156, Germany
Charité Universitätsmedizin Berlin, CVK, Onkologie
Berlin, 13353, Germany
Evangelisches Krankenhaus Bielefeld gGmbH, Onkologie
Bielefeld, 33617, Germany
Universitätsklinikum Bonn, Onkologie
Bonn, 53113, Germany
Klinikum Bremen-Mitte gGmbH, Onkologie
Bremen, 25117, Germany
Uniklinik Köln, Pädiatrische Onkologie
Cologne, 50937, Germany
Kliniken der Stadt Köln gGmbH
Cologne, Germany
Universitätsklinikum Düsseldorf, Onkologie
Düsseldorf, 40225, Germany
Universitätsklinikum Essen, Onkologie
Essen, 45122, Germany
Klinik für Nuklearmedizin
Freiburg im Breisgau, 79106, Germany
Klinik für Pädiatrische Hämatologie und Onkologie
Freiburg im Breisgau, 79106, Germany
Zentrum für Kinder- und Jugendmedizin, Angelika-Lautenschläger-Klinik, Onkologie
Heidelberg, 69120, Germany
Institut für Neurowissenschaften und Medizin, Physik der medizinischen Bildgebung, Forschungszentrum Jülich, Nuklearmedizin
Jülich, 52425, Germany
Universitätsklinikum Mainz, Onkologie
Mainz, 55131, Germany
Kinderklinik München Schwabing, Onkologie
München, 80804, Germany
Nuklearmedizinische Klinik und Poliklinik
München, 81675, Germany
Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
Münster, 48149, Germany
Klinik für Nuklearmedizin
Münster, 48149, Germany
Klinikum Stuttgart - Olgahospital, Onkologie
Stuttgart, 70174, Germany
Klinikum Stuttgart, Nuklearmedizin
Stuttgart, 70174, Germany
Universitätsklinikum Tübingen, Onkologie
Tübingen, 72076, Germany
Universitäts-Kinderklinik Würzburg
Würzburg, 97060, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo Hernáiz Driever, MD
Charite University, Berlin, Germany
- STUDY CHAIR
Michail Plotkin, MD
Vivantes Klinikum
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 10, 2017
First Posted
July 13, 2017
Study Start
July 1, 2015
Primary Completion
July 1, 2018
Study Completion
July 1, 2019
Last Updated
July 21, 2017
Record last verified: 2017-07