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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Bogdana Suchorska, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01089244
First received: March 17, 2010
Last updated: August 5, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Astrocytoma
Oligoastrocytoma
Oligodendroglioma

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

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)
Groups/Cohorts
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

  Eligibility

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

Criteria

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

Locations
Germany
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)
Investigators
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
Astrocytoma
Molecular imaging
 FET PET
Therapy monitoring
Temodar

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

ClinicalTrials.gov processed this record on May 19, 2013