Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Patients who suffer from a suspected GBM and will undergo a microsurgical procedure for diagnosis verification. MRI and Positron Emission Tomography (PET) scans are scheduled prior to microsurgery, post microsurgery and after having completed radiochemotherapy and an additional scan after TMZ chemotherapy.

Patients enrolled in Group B suffer from a suspected GBM which cannot be accessed microsurgically either due to a an eloquent location of the tumor, or patient's refusal to undergo surgery. In these patients, diagnosis will be obtained by means of stereotactic surgery. After an initial PET and MRI scan prior to biopsy, patients will be monitored by post radiochemotherapy as well as post 3-months chemotherapy MRI/PET scans.

Joerg C. Tonn, Prof. Dr.

The aim of this study is to establish FET-PET as an additional therapy assessment parameter in patients diagnosed with a glioblastoma multiforme receiving radiochemotherapy and adjuvant chemotherapy after previous resection or biopsy.

DNA and RNA samples for MGMT methylation and LOH 1p and 19q status analysis

Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients

Quantification of Therapy Effects After Microsurgery, Percutaneous Irradiation and Chemotherapy by FET-PET Analysis

Deutsche Krebshilfe e.V., Bonn (Germany)

Ludwig-Maximilians - University of Munich

Symptoms and General Pathology

Body Weight

Oligodendroglioma

Oligoastrocytoma

Patients with a suspected WHO II low grade glioma, disease progression within

1 year

Patients with a suspected WHO II low grade glioma, progression free within 1 year

The aim of the study is to compare the two imaging modalities perfusion weighted MR-imaging and FET-PET in their ability to provide an accurate histological evaluation of low grade glioma and to reveal focal abnormalities within a homogeneously appearing tumor. Additionally, therapeutic effects should be assessed during a time period of two years.

High molecular wight DNA and RNA speciments for MGMT promoter methylation, IDH1/IDH2 and p53 mutation, LOH 1p and 19q analysis

FET-PET for Diagnosis and Monitoring in Patients With Low Grade Glioma

Molecular Correlates and Clinical Significance of Positron Emission Tomography With FET-PET in Combination With Perfusion-weighted Magnetic Resonance Imaging (PWI) in Patients With Low Grade Gliomas

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Childhood

Amino Acids

Tyrosine

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)

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)

FET-PET

Uwe Behrens, PhD

Ramona Stöckl

Michael Frühwald, Prof. Dr.

Pablo Hernaiz Driever, MD

Norbert Jorch, Dr.

Dagmar Dilloo, Prof. Dr.

Stefan Schönberger, MD

Arnulf Pekrun, Prof. Dr.

Stefan Balzer, MD

Julia Hauer, MD

Gudrun Fleischhack, Prof. Dr.

Michael Schündeln, MD

Thorsten Pöppel, MD

Michael Forsting, Prof.

Philipp T Meyer, Prof. Dr.

Timo Spehl, MD

Charlotte Niemeyer, Prof. Dr.

Jochen Rösler, Prof. Dr.

Olaf Witt, Prof. Dr.

Till Milde, MD

Uwe Haberkorn, Prof. Dr.

Sabine Haufe, MD

Karl-Josef Langen, Prof. Dr.

Thorsten Simon, Prof. Dr.

Barbara Hero, MD

Aram Prokop, MD

Stephan Lobitz, MD

Manol Velev, MD

Jörg Faber, Dr.

Alexandra Russo, MD

Matthias Miederer, MD

Julia Köhle, Dr.

Irene Teichert von Lüttichau, MD

Stefan Förster, Dr.

Ronald Sträter, MD

Cornelius Kerl

Matthias Weckesser, Prof. Dr.

Kambiz Rahar

Stefan Bielack, Prof. Dr.

Stephanie Knirsch, MD

Gabriele Pöpperl, Prof. Dr.

Marcus Nicolai, MD

Martin Ebinger, Dr.

Carl-Philipp Schwarze, MD

Paul-Gerhardt Schlegel, Prof. Dr.

Matthias Eyrich, Prof. Dr.

Pablo Hernáiz Driever, MD

Michail Plotkin, MD

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

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.

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.

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

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)

To assess sensitivity of FET PET in comparison with the sensitivity of MRI (Δ sensitivityFET PET to sensitivityMRT)

(PPV, NPV) of FET PET in comparison with the PPV and NPV of MRI (Δ NPVFET PET to NPVMRT)

SUVratio analyses of FET PET data to allow for Analysis of Tumor grading when histological results are available

To assess adverse events and toxicity Profile using Common Terminology Criteria for Adverse Events, CTCAE v4.03

Charite University, Berlin, Germany

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients	NCT01089868	Glioblastoma Mu...		18 Years -	Ludwig-Maximilians - University of Munich
FET-PET for Diagnosis and Monitoring in Patients With Low Grade Glioma	NCT01089244	Astrocytoma Oligoastrocytom... Oligodendroglio...		18 Years -	Ludwig-Maximilians - University of Munich
FET-PET for Diagnosis and Monitoring in Patients With Low Grade Glioma	NCT01089244	Astrocytoma Oligoastrocytom... Oligodendroglio...		18 Years -	Ludwig-Maximilians - University of Munich
18F-FET PET in Childhood Brain Tumours	NCT03216148	Brain Neoplasm	FET-PET	1 Year - 17 Years	Charite University, Berlin, Germany

Spots Global Cancer Trial Database for fet pet

Every month we try and update this database with for fet pet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fet pet

Every month we try and update this database with for fet pet cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fet pet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.