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Brain NeoplasmPhase 2NCT03216148

18F-FET PET in Childhood Brain Tumours

A Phase 2 study testing FET-PET in people with Brain Neoplasm, run by Charite University, Berlin, Germany at 22 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 1 year to 17 years
Conditions the study is for
Brain Neoplasm
What is being tested?
FET-PET
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
22 sitesGermany
Study dates
Jul 2015to Jul 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

22 sites in 1 country.

Uwe Behrens, PhD contact

uwe.behrens@charite.de

Ramona Stöckl contact

ramona.stoeckl@charite.de

22 sites in 1 country

Germany22 sites, 22 recruiting

  • Klinikum Augsburg, Onkologie

    Augsburg, 86156

    Michael Frühwald, Prof. Dr.

    Not yet recruiting

  • Charité Universitätsmedizin Berlin, CVK, Onkologie

    Berlin, 13353

    Pablo Hernaiz Driever, MD, +49 30 450 666173, pablo.hernaiz@charite.de

    Recruiting

  • Evangelisches Krankenhaus Bielefeld gGmbH, Onkologie

    Bielefeld, 33617

    Norbert Jorch, Dr.

    Not yet recruiting

  • Universitätsklinikum Bonn, Onkologie

    Bonn, 53113

    Dagmar Dilloo, Prof. Dr.

    Stefan Schönberger, MD

    Recruiting

  • Klinikum Bremen-Mitte gGmbH, Onkologie

    Bremen, 25117

    Arnulf Pekrun, Prof. Dr.

    Not yet recruiting

  • Uniklinik Köln, Pädiatrische Onkologie

    Cologne, 50937

    Thorsten Simon, Prof. Dr.

    Barbara Hero, MD

    Recruiting

  • Kliniken der Stadt Köln gGmbH

    Cologne

    Aram Prokop, MD

    Stephan Lobitz, MD

    Recruiting

  • Universitätsklinikum Düsseldorf, Onkologie

    Düsseldorf, 40225

    Stefan Balzer, MD

    Julia Hauer, MD

    Not yet recruiting

  • Universitätsklinikum Essen, Onkologie

    Essen, 45122

    Gudrun Fleischhack, Prof. Dr.

    Michael Schündeln, MD

    Recruiting

  • Klinik für Nuklearmedizin

    Freiburg im Breisgau, 79106

    Philipp T Meyer, Prof. Dr., +49 761 270 39160, sek.nuklearmedizin@uniklinik-freiburg.de

    Timo Spehl, MD

    Recruiting

  • Klinik für Pädiatrische Hämatologie und Onkologie

    Freiburg im Breisgau, 79106

    Charlotte Niemeyer, Prof. Dr.

    Jochen Rösler, Prof. Dr.

    Recruiting

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

    Heidelberg, 69120

    Olaf Witt, Prof. Dr.

    Till Milde, MD

    Recruiting

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

    Jülich, 52425

    Karl-Josef Langen, Prof. Dr.

    Recruiting

  • Universitätsklinikum Mainz, Onkologie

    Mainz, 55131

    Jörg Faber, Dr.

    Alexandra Russo, MD

    Recruiting

  • Kinderklinik München Schwabing, Onkologie

    München, 80804

    Julia Köhle, Dr.

    Irene Teichert von Lüttichau, MD

    Not yet recruiting

  • Nuklearmedizinische Klinik und Poliklinik

    München, 81675

    Stefan Förster, Dr.

    Not yet recruiting

  • Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie

    Münster, 48149

    Ronald Sträter, MD

    Cornelius Kerl

    Not yet recruiting

  • Klinik für Nuklearmedizin

    Münster, 48149

    Matthias Weckesser, Prof. Dr.

    Kambiz Rahar

    Not yet recruiting

  • Klinikum Stuttgart - Olgahospital, Onkologie

    Stuttgart, 70174

    Stefan Bielack, Prof. Dr.

    Stephanie Knirsch, MD

    Recruiting

  • Klinikum Stuttgart, Nuklearmedizin

    Stuttgart, 70174

    Gabriele Pöpperl, Prof. Dr.

    Marcus Nicolai, MD

    Recruiting

  • Universitätsklinikum Tübingen, Onkologie

    Tübingen, 72076

    Martin Ebinger, Dr.

    Carl-Philipp Schwarze, MD

    Not yet recruiting

  • Universitäts-Kinderklinik Würzburg

    Würzburg, 97060

    Paul-Gerhardt Schlegel, Prof. Dr.

    Matthias Eyrich, Prof. Dr.

    Not yet recruiting

Other trials in Germany

About this study

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

Read the 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
Being tested
FET-PET
Keywords
FET PET
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FET-PETDiagnostic test

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

    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)

Study groups in NCT03216148
Study groupRoleWhat they receive
FET-PETExperimentalAll 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)
Receives: Diagnostic Test: FET-PET

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 years

Secondary outcomes (4)

  1. 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 (Δ sensitivityFET PET to sensitivityMRT)

    Measured: 3 years

  2. 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 (Δ NPVFET PET to NPVMRT)

    Measured: 4 years

  3. 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

    Measured: 4 years

  4. 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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2017
  2. Study startJul 2015
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
All pediatric patients with brain Tumor receive a FET-PET Investigation in Addition to conventional MRI at the end of the first-line therapy. In case of Progression or Relapse patients may receive a second FET-PET Investigation in Addition to Routine surveillance MRI.
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03216148
Sponsor's protocol ID
FET PET 2010
Other IDs
2008-005786-60, 2008
Status last verified
Jul 2017
First submitted
10 Jul 2017
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FET-PET in people with Brain Neoplasm, run by Charite University, Berlin, Germany at 22 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Uwe Behrens, PhD (uwe.behrens@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differentiating biologically active Tumor tissue from therapy related changes by using MRI (Magnetic Resonance Imaging) and FET PET (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03216148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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