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

This study is ongoing, but not recruiting participants.
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Bogdana Suchorska, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
First received: March 17, 2010
Last updated: August 5, 2012
Last verified: August 2012

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Group A

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

1 year

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a suspected referred to a Neurosurgical Department in order to provide a diagnosis and therapy


Inclusion Criteria:

  • neuroradiologically suspected low grade glioma (Astrocytoma WHOI-II, Oligodendroglioma WHO II, Oligoastrocytoma WHO II)
  • histological verification will be obtained either by microsurgery or by stereotactic biopsy
  • patients older than 18 years
  • Karnofsky Performance Score >=70
  • pregnant or nursing female patients will not be included in this study

Exclusion Criteria:

  • patients in whom informed consent cannot be obtained due to organic brain syndrome or insufficient language skills
  • patients who cannot lie quiet for a time period of app. two hours during the FET-PEt scan
  • medical history of a metastatic brain disease
  • patients in whom an MRI scan cannot be performed due to claustrophobia metallic protheses or pacemakers etc.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089244

University Hospital Munich, Department of Neurosurgery
Munich, Bavaria, Germany, 81377
University Hospital, Duesseldorf
Duesseldorf, North Rhine-Westphalia, Germany, 40225
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Deutsche Krebshilfe e.V., Bonn (Germany)
Principal Investigator: Joerg C. Tonn, Prof. Dr. Department of Neurosurgery, LMU Munich
  More Information

No publications provided

Responsible Party: Bogdana Suchorska, PI, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01089244     History of Changes
Other Study ID Numbers: GGN-CP4
Study First Received: March 17, 2010
Last Updated: August 5, 2012
Health Authority: Germany: Federal Office for Radiation Protection

Keywords provided by Ludwig-Maximilians - University of Munich:
Low grade glioma
Molecular imaging
Therapy monitoring

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on April 17, 2014