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

NCT ID: NCT01089244

Last Updated: 2015-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Astrocytoma Oligoastrocytoma Oligodendroglioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

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

1 year

No interventions assigned to this group

Group B

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Bogdana Suchorska

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joerg C. Tonn, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, LMU Munich

Locations

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University Hospital Munich, Department of Neurosurgery

Munich, Bavaria, Germany

Site Status

University Hospital, Duesseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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GGN-CP4

Identifier Type: -

Identifier Source: org_study_id

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