- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01089244
FET-PET for Diagnosis and Monitoring in Patients With Low Grade Glioma
September 18, 2015 updated by: Bogdana Suchorska, Ludwig-Maximilians - University of Munich
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
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
Munich, Bavaria, Germany, 81377
- University Hospital Munich, Department of Neurosurgery
-
-
North Rhine-Westphalia
-
Duesseldorf, North Rhine-Westphalia, Germany, 40225
- University Hospital, Duesseldorf
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with a suspected referred to a Neurosurgical Department in order to provide a diagnosis and therapy
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free survival
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joerg C. Tonn, Prof. Dr., Department of Neurosurgery, LMU Munich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
March 17, 2010
First Submitted That Met QC Criteria
March 17, 2010
First Posted (Estimate)
March 18, 2010
Study Record Updates
Last Update Posted (Estimate)
September 22, 2015
Last Update Submitted That Met QC Criteria
September 18, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GGN-CP4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Astrocytoma
-
St. Jude Children's Research HospitalRecruitingGlioma | Ganglioglioma | Pleomorphic Xanthoastrocytoma | Diffuse Astrocytoma | Pilocytic Astrocytoma | Optic Pathway Glioma | Pilomyxoid AstrocytomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Childhood Ependymoma | Childhood Infratentorial Ependymoma | Childhood Supratentorial Ependymoma | Recurrent Childhood Cerebellar Astrocytoma | Recurrent Childhood Cerebral Astrocytoma | Recurrent Childhood Subependymal Giant Cell Astrocytoma | Childhood Mixed Glioma | Childhood Oligodendroglioma and other conditionsUnited States, Canada, Australia
-
Erik MittraNational Cancer Institute (NCI)TerminatedUntreated Childhood Brain Stem Glioma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Oligodendroglioma | Adult Pilocytic Astrocytoma | Adult Pineal Gland Astrocytoma and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedAdult Anaplastic Astrocytoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Pilocytic Astrocytoma | Adult Pineal Gland Astrocytoma | Recurrent Adult Brain Tumor | Adult Subependymal Giant...United States
-
National Cancer Institute (NCI)Active, not recruitingAstrocytoma, IDH-Mutant, Grade 2 | Astrocytoma, IDH-Mutant, Grade 3United States
-
Washington University School of MedicineCompletedAstrocytoma, Grade III | Astrocytoma, Grade IV | Grade IV Astrocytoma | Grade III AstrocytomaUnited States
-
National Cancer Institute (NCI)CompletedChildhood High-grade Cerebellar Astrocytoma | Childhood High-grade Cerebral Astrocytoma | Recurrent Childhood Anaplastic Astrocytoma | Recurrent Childhood Anaplastic Oligoastrocytoma | Recurrent Childhood Anaplastic Oligodendroglioma | Recurrent Childhood Cerebellar Astrocytoma | Recurrent Childhood... and other conditionsUnited States, Canada
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Ependymoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Myxopapillary Ependymoma | Adult Oligodendroglioma | Adult Pilocytic... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Millennium Pharmaceuticals, Inc.CompletedAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Oligodendroglioma | Adult Pilocytic Astrocytoma | Adult Pineal Gland Astrocytoma | Recurrent... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedAdult Anaplastic Astrocytoma | Adult Diffuse Astrocytoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Oligodendroglioma | Adult Pineal Gland AstrocytomaUnited States