18F-FET PET in Childhood Brain Tumours

NCT ID: NCT03216148

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2019-07-31

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

Detailed Description

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. 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.

Conditions

Brain Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FET-PET

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)

Group Type: EXPERIMENTAL

FET-PET

Intervention Type: DIAGNOSTIC_TEST

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)

Interventions

FET-PET

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)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

O-(2-[18F]Fluoroethyl)-L-Tyrosine

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. Pablo Hernaiz Driever

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pablo Hernáiz Driever, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Michail Plotkin, MD

Role: STUDY_CHAIR

Vivantes Klinikum

Locations

Klinikum Augsburg, Onkologie

Augsburg, , Germany

Site Status: NOT_YET_RECRUITING

Charité Universitätsmedizin Berlin, CVK, Onkologie

Berlin, , Germany

Site Status: RECRUITING

Evangelisches Krankenhaus Bielefeld gGmbH, Onkologie

Bielefeld, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Bonn, Onkologie

Bonn, , Germany

Site Status: RECRUITING

Klinikum Bremen-Mitte gGmbH, Onkologie

Bremen, , Germany

Site Status: NOT_YET_RECRUITING

Uniklinik Köln, Pädiatrische Onkologie

Cologne, , Germany

Site Status: RECRUITING

Kliniken der Stadt Köln gGmbH

Cologne, , Germany

Site Status: RECRUITING

Universitätsklinikum Düsseldorf, Onkologie

Düsseldorf, , Germany

Site Status: NOT_YET_RECRUITING

Universitätsklinikum Essen, Onkologie

Essen, , Germany

Site Status: RECRUITING

Klinik für Nuklearmedizin

Freiburg im Breisgau, , Germany

Site Status: RECRUITING

Klinik für Pädiatrische Hämatologie und Onkologie

Freiburg im Breisgau, , Germany

Site Status: RECRUITING

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

Heidelberg, , Germany

Site Status: RECRUITING

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

Jülich, , Germany

Site Status: RECRUITING

Universitätsklinikum Mainz, Onkologie

Mainz, , Germany

Site Status: RECRUITING

Kinderklinik München Schwabing, Onkologie

München, , Germany

Site Status: NOT_YET_RECRUITING

Nuklearmedizinische Klinik und Poliklinik

München, , Germany

Site Status: NOT_YET_RECRUITING

Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie

Münster, , Germany

Site Status: NOT_YET_RECRUITING

Klinik für Nuklearmedizin

Münster, , Germany

Site Status: NOT_YET_RECRUITING

Klinikum Stuttgart - Olgahospital, Onkologie

Stuttgart, , Germany

Site Status: RECRUITING

Klinikum Stuttgart, Nuklearmedizin

Stuttgart, , Germany

Site Status: RECRUITING

Universitätsklinikum Tübingen, Onkologie

Tübingen, , Germany

Site Status: NOT_YET_RECRUITING

Universitäts-Kinderklinik Würzburg

Würzburg, , Germany

Site Status: NOT_YET_RECRUITING

Countries

Germany

Central Contacts

Uwe Behrens, PhD

Role: CONTACT

uwe.behrens@charite.de

Ramona Stöckl

Role: CONTACT

ramona.stoeckl@charite.de

Facility Contacts

Michael Frühwald, Prof. Dr.

Role: primary

Pablo Hernaiz Driever, MD

Role: primary

pablo.hernaiz@charite.de

+49 30 450 666173

Norbert Jorch, Dr.

Role: primary

Dagmar Dilloo, Prof. Dr.

Role: primary

Stefan Schönberger, MD

Role: backup

Arnulf Pekrun, Prof. Dr.

Role: primary

Thorsten Simon, Prof. Dr.

Role: primary

Barbara Hero, MD

Role: backup

Aram Prokop, MD

Role: primary

Stephan Lobitz, MD

Role: backup

Stefan Balzer, MD

Role: primary

Julia Hauer, MD

Role: backup

Gudrun Fleischhack, Prof. Dr.

Role: primary

Michael Schündeln, MD

Role: backup

Philipp T Meyer, Prof. Dr.

Role: primary

sek.nuklearmedizin@uniklinik-freiburg.de

+49 761 270 39160

Timo Spehl, MD

Role: backup

Charlotte Niemeyer, Prof. Dr.

Role: primary

Jochen Rösler, Prof. Dr.

Role: backup

Olaf Witt, Prof. Dr.

Role: primary

Till Milde, MD

Role: backup

Karl-Josef Langen, Prof. Dr.

Role: primary

Jörg Faber, Dr.

Role: primary

Alexandra Russo, MD

Role: backup

Julia Köhle, Dr.

Role: primary

Irene Teichert von Lüttichau, MD

Role: backup

Stefan Förster, Dr.

Role: primary

Ronald Sträter, MD

Role: primary

Cornelius Kerl

Role: backup

Matthias Weckesser, Prof. Dr.

Role: primary

Kambiz Rahar

Role: backup

Stefan Bielack, Prof. Dr.

Role: primary

Stephanie Knirsch, MD

Role: backup

Gabriele Pöpperl, Prof. Dr.

Role: primary

Marcus Nicolai, MD

Role: backup

Martin Ebinger, Dr.

Role: primary

Carl-Philipp Schwarze, MD

Role: backup

Paul-Gerhardt Schlegel, Prof. Dr.

Role: primary

Matthias Eyrich, Prof. Dr.

Role: backup

Other Identifiers

2008-005786-60

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FET PET 2010

Identifier Type: -

Identifier Source: org_study_id