AstrocytomaNCT01089244
FET-PET for Diagnosis and Monitoring in Patients With Low Grade Glioma
An observational study of Astrocytoma and Oligoastrocytoma, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytoma, Oligoastrocytoma, Oligodendroglioma
- How many people
- 38 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2008to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a suspected referred to a Neurosurgical Department in order to provide a diagnosis and therapy
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital, Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
University Hospital Munich, Department of Neurosurgery
Munich, Bavaria, 81377
About this study
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
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
- Medical subject headings
- Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 24 months
Secondary outcomes (1)
Progression Free survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startJun 2008
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Responsible party
- Principal investigator, Bogdana Suchorska, Ludwig-Maximilians - University of Munich
- Investigators
- Joerg C. Tonn, Prof. Dr., Principal investigator, Department of Neurosurgery, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089244
- Sponsor's protocol ID
- GGN-CP4
- Status last verified
- Sep 2015
- First submitted
- 17 Mar 2010
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01089244
- Acronym / sponsor ID
- GGN-CP4
- Conditions
- Astrocytoma, Oligoastrocytoma, Oligodendroglioma
- Keywords
- Low grade glioma, Astrocytoma, Molecular imaging, FET PET, Therapy monitoring, Temodar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- Jun 2008
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a suspected referred to a Neurosurgical Department in order to provide a diagnosis and therapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 24 months
1 secondary outcome
Progression Free survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg C. Tonn, Prof. Dr. principal investigator
Department of Neurosurgery, LMU Munich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Astrocytoma and Oligoastrocytoma, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.