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

NCT01089244 | Unknown

• 1 other identifier: GGN-CP4
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Astrocytoma; Oligoastrocytoma; Oligodendroglioma

Keywords

Low grade glioma; Astrocytoma; Molecular imaging; FET PET; Therapy monitoring; Temodar

Outcome Measures

Primary Outcomes (1)

• Overall survival

  24 months

Secondary Outcomes (1)

• Progression Free survival

  24 months

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a suspected referred to a Neurosurgical Department in order to provide a diagnosis and therapy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator

Study Sites (2)

University Hospital Munich, Department of Neurosurgery

Munich, Bavaria, 81377, Germany

Location

University Hospital, Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

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

MeSH Terms

Conditions

Astrocytoma; Oligodendroglioma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Joerg C. Tonn, Prof. Dr.

  Department of Neurosurgery, LMU Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: June 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

DE (2)