Clinical Trial Finder

18F-FET PET in Childhood Brain Tumours

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 1 Year - 17 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03216148

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Charite University, Berlin, Germany

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries Germany

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Brain Neoplasm
Additional Details

2.1 Primary objective The main objective is to evaluate the relative benefit of FET PET in comparison to the MRI in differentiating biologically active tumour tissue from therapy-related changes in paediatric brain tumours after first line therapy (Δ specificityFET PET to specificityMRT) 2.2 Secondary Objectives To assess sensitivity of FET PET in comparison with the sensitivity of MRI (Δ sensitivityFET PET to sensitivityMRT) To assess the positive and negative predictive values (PPV, NPV) of FET PET in comparison with the PPV and NPV of MRI (Δ PPVFET PET to PPVMRT, Δ 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.#46; III/IV) by kinetic studies when histology is available To assess adverse events and toxicity profile 2.3 Endpoints (Standard of truth1) 2.3.1 Primary Endpoint The primary endpoint is an event free survival of the follow-up period of 24 (12) months after first line therapy (confirmed by clinical and neuroradiological assessment) or the confirmed diagnosis of progression or recurrence of brain tumour tissue (confirmed by histology or clinical and neuroradiological assessment). The follow-up period for patients with a low risk of tumour recurrence after first line therapy, i.e. astrocytoma WHO grade I-II, oligodendroglioma WHO grade I-II, germ cell tumour, choroid plexus tumour, craniopharyngioma will be 24 months. The follow-up period for patients with a high risk of tumour recurrence after first line therapy, i.e. astrocytoma WHO grade III-IV, oligodendroglioma WHO grade III-IV, medulloblastoma, supratentorial PNET, AT/RT and other high-grade tumour lesions will be 12 months. 2.3.2 Secondary Endpoints To assess the secondary objectives of the FET PET 2010 study, the investigators will determine event free survival of the follow-up period of 24 (12) months after first line therapy (confirmed by clinical and neuroradiological assessment) or the confirmed diagnosis of progression or recurrence of brain tumour tissue (confirmed by histology or clinical and neuroradiological assessment). Histopathological characteristics of recurrent tumours (WHO grade I-IV) Safety and Toxicity (evolution according to CTCEA v3.0 criteria): the NCI Common Terminology Criteria for Adverse Events v3.0 is a descriptive terminology, that is used for Adverse Event (AE) reporting. A grading scale is provided for each AE term. Attached is a selection of categories, which are required to assess safety and toxicity of FET PET examinations.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Klinikum Augsburg, Onkologie, Augsburg, Germany

Status

Not yet recruiting

Address

Klinikum Augsburg, Onkologie

Augsburg, , 86156

Site Contact

Michael Frühwald, Prof. Dr.

Berlin, Germany

Status

Recruiting

Address

Charité Universitätsmedizin Berlin, CVK, Onkologie

Berlin, , 13353

Site Contact

Pablo Hernaiz Driever, MD

pablo.hernaiz@charite.de

+49 30 450 666173

Bielefeld, Germany

Status

Not yet recruiting

Address

Evangelisches Krankenhaus Bielefeld gGmbH, Onkologie

Bielefeld, , 33617

Site Contact

Norbert Jorch, Dr.

Universitätsklinikum Bonn, Onkologie, Bonn, Germany

Status

Recruiting

Address

Universitätsklinikum Bonn, Onkologie

Bonn, , 53113

Site Contact

Dagmar Dilloo, Prof. Dr.

Klinikum Bremen-Mitte gGmbH, Onkologie, Bremen, Germany

Status

Not yet recruiting

Address

Klinikum Bremen-Mitte gGmbH, Onkologie

Bremen, , 25117

Site Contact

Arnulf Pekrun, Prof. Dr.

Düsseldorf, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Düsseldorf, Onkologie

Düsseldorf, , 40225

Site Contact

Stefan Balzer, MD

Universitätsklinikum Essen, Onkologie, Essen, Germany

Status

Recruiting

Address

Universitätsklinikum Essen, Onkologie

Essen, , 45122

Site Contact

Gudrun Fleischhack, Prof. Dr.

Klinik für Nuklearmedizin, Freiburg, Germany

Status

Recruiting

Address

Klinik für Nuklearmedizin

Freiburg, , 79106

Site Contact

Philipp T Meyer, Prof. Dr.

sek.nuklearmedizin@uniklinik-freiburg.de

+49 761 270 39160

Freiburg, Germany

Status

Recruiting

Address

Klinik für Pädiatrische Hämatologie und Onkologie

Freiburg, , 79106

Site Contact

Charlotte Niemeyer, Prof. Dr.

Heidelberg, Germany

Status

Recruiting

Address

Zentrum für Kinder- und Jugendmedizin, Angelika-Lautenschläger-Klinik, Onkologie

Heidelberg, , 69120

Site Contact

Olaf Witt, Prof. Dr.

Jülich, Germany

Status

Recruiting

Address

Institut für Neurowissenschaften und Medizin, Physik der medizinischen Bildgebung, Forschungszentrum Jülich, Nuklearmedizin

Jülich, , 52425

Site Contact

Karl-Josef Langen, Prof. Dr.

Uniklinik Köln, Pädiatrische Onkologie, Köln, Germany

Status

Recruiting

Address

Uniklinik Köln, Pädiatrische Onkologie

Köln, , 50937

Site Contact

Thorsten Simon, Prof. Dr.

Kliniken der Stadt Köln gGmbH, Köln, Germany

Status

Recruiting

Address

Kliniken der Stadt Köln gGmbH

Köln, ,

Site Contact

Aram Prokop, MD

Universitätsklinikum Mainz, Onkologie, Mainz, Germany

Status

Recruiting

Address

Universitätsklinikum Mainz, Onkologie

Mainz, , 55131

Site Contact

Jörg Faber, Dr.

München, Germany

Status

Not yet recruiting

Address

Kinderklinik München Schwabing, Onkologie

München, , 80804

Site Contact

Julia Köhle, Dr.

München, Germany

Status

Not yet recruiting

Address

Nuklearmedizinische Klinik und Poliklinik

München, , 81675

Site Contact

Stefan Förster, Dr.

Münster, Germany

Status

Not yet recruiting

Address

Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie

Münster, , 48149

Site Contact

Ronald Sträter, MD

Klinik für Nuklearmedizin, Münster, Germany

Status

Not yet recruiting

Address

Klinik für Nuklearmedizin

Münster, , 48149

Site Contact

Matthias Weckesser, Prof. Dr.

Stuttgart, Germany

Status

Recruiting

Address

Klinikum Stuttgart - Olgahospital, Onkologie

Stuttgart, , 70174

Site Contact

Stefan Bielack, Prof. Dr.

Klinikum Stuttgart, Nuklearmedizin, Stuttgart, Germany

Status

Recruiting

Address

Klinikum Stuttgart, Nuklearmedizin

Stuttgart, , 70174

Site Contact

Gabriele Pöpperl, Prof. Dr.

Universitätsklinikum Tübingen, Onkologie, Tübingen, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Tübingen, Onkologie

Tübingen, , 72076

Site Contact

Martin Ebinger, Dr.

Universitäts-Kinderklinik Würzburg, Würzburg, Germany

Status

Not yet recruiting

Address

Universitäts-Kinderklinik Würzburg

Würzburg, , 97060

Site Contact

Paul-Gerhardt Schlegel, Prof. Dr.

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