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

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ClinicalTrials.gov Identifier: NCT01089244
Recruitment Status : Unknown
Verified September 2015 by Bogdana Suchorska, Ludwig-Maximilians - University of Munich.
Recruitment status was:  Active, not recruiting
First Posted : March 18, 2010
Last Update Posted : September 22, 2015
Sponsor:
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Bogdana Suchorska, Ludwig-Maximilians - University of Munich

Brief Summary:
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 or disease
Astrocytoma Oligoastrocytoma Oligodendroglioma

Study Type : Observational
Actual Enrollment : 38 participants
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
Study Start Date : June 2008
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Progression Free survival [ Time Frame: 24 months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bogdana Suchorska, PI, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01089244     History of Changes
Other Study ID Numbers: GGN-CP4
First Posted: March 18, 2010    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by Bogdana Suchorska, Ludwig-Maximilians - University of Munich:
Low grade glioma
Astrocytoma
Molecular imaging
FET PET
Therapy monitoring
Temodar

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