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

Sponsor
Ludwig-Maximilians - University of Munich (Other)
Overall Status
Unknown status
CT.gov ID
NCT01089244
Collaborator
Deutsche Krebshilfe e.V., Bonn (Germany) (Other)
38
Enrollment
2
Locations
90
Duration (Months)
19
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jun 1, 2008
    Anticipated Primary Completion Date :
    Dec 1, 2015
    Anticipated Study Completion Date :
    Dec 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [24 months]

    Secondary Outcome Measures

    1. Progression Free survival [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University Hospital Munich, Department of Neurosurgery Munich Bavaria Germany 81377
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bogdana Suchorska, PI, Ludwig-Maximilians - University of Munich
    ClinicalTrials.gov Identifier:
    NCT01089244
    Other Study ID Numbers:
    • GGN-CP4
    First Posted:
    Mar 18, 2010
    Last Update Posted:
    Sep 22, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Bogdana Suchorska, PI, Ludwig-Maximilians - University of Munich
    Low grade glioma
    Astrocytoma
    Molecular imaging
    FET PET
    Therapy monitoring
    Temodar
    Additional relevant MeSH terms:
    Glioma
    Astrocytoma
    Oligodendroglioma

    Study Results

    No Results Posted as of Sep 22, 2015