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

Astrocytoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01089244
• Other study ID #: GGN-CP4
• Status: Active, not recruiting
• Phase: N/A
• First received: March 17, 2010
• Last updated: September 18, 2015
• Start date: June 2008
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Office for Radiation Protection
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Astrocytoma
• Oligoastrocytoma
• Oligodendroglioma

Locations

Country	Name	City	State
Germany	University Hospital, Duesseldorf	Duesseldorf	North Rhine-Westphalia
Germany	University Hospital Munich, Department of Neurosurgery	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		24 months	No
Secondary	Progression Free survival		24 months	No