Brain Neoplasm Clinical Trial
Official title:
A Prospective, Multicentre Trial on the Value of 18F-FET PET in the Post-therapeutic Evaluation of Childhood Brain Tumours
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
Status | Recruiting |
Enrollment | 160 |
Est. completion date | July 2019 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Augsburg, Onkologie | Augsburg | |
Germany | Charité Universitätsmedizin Berlin, CVK, Onkologie | Berlin | |
Germany | Evangelisches Krankenhaus Bielefeld gGmbH, Onkologie | Bielefeld | |
Germany | Universitätsklinikum Bonn, Onkologie | Bonn | |
Germany | Klinikum Bremen-Mitte gGmbH, Onkologie | Bremen | |
Germany | Universitätsklinikum Düsseldorf, Onkologie | Düsseldorf | |
Germany | Universitätsklinikum Essen, Onkologie | Essen | |
Germany | Klinik für Nuklearmedizin | Freiburg | |
Germany | Klinik für Pädiatrische Hämatologie und Onkologie | Freiburg | |
Germany | Zentrum für Kinder- und Jugendmedizin, Angelika-Lautenschläger-Klinik, Onkologie | Heidelberg | |
Germany | Institut für Neurowissenschaften und Medizin, Physik der medizinischen Bildgebung, Forschungszentrum Jülich, Nuklearmedizin | Jülich | |
Germany | Kliniken der Stadt Köln gGmbH | Köln | |
Germany | Uniklinik Köln, Pädiatrische Onkologie | Köln | |
Germany | Universitätsklinikum Mainz, Onkologie | Mainz | |
Germany | Kinderklinik München Schwabing, Onkologie | München | |
Germany | Nuklearmedizinische Klinik und Poliklinik | München | |
Germany | Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie | Münster | |
Germany | Klinik für Nuklearmedizin | Münster | |
Germany | Klinikum Stuttgart - Olgahospital, Onkologie | Stuttgart | |
Germany | Klinikum Stuttgart, Nuklearmedizin | Stuttgart | |
Germany | Universitätsklinikum Tübingen, Onkologie | Tübingen | |
Germany | Universitäts-Kinderklinik Würzburg | Würzburg |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 (? specificityFET PET to specificityMRT) | 3 years | |
Secondary | Sensitivity of FET-PET when differentiating biologically active Tumor tissue from therapy-related changes by using MRI (Magnetic Resonance Imaging) and FET PET | To assess sensitivity of FET PET in comparison with the sensitivity of MRI (? sensitivityFET PET to sensitivityMRT) | 3 years | |
Secondary | 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 | (PPV, NPV) of FET PET in comparison with the PPV and NPV of MRI (? NPVFET PET to NPVMRT) | 4 years | |
Secondary | 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 | SUVratio analyses of FET PET data to allow for Analysis of Tumor grading when histological results are available | 4 years | |
Secondary | Safety data on FET-PET in children with brain tumors | To assess adverse events and toxicity Profile using Common Terminology Criteria for Adverse Events, CTCAE v4.03 | 3 years |
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