GliomaGliomes-FLPNCT00939315
Multimodal Diagnostic Assessment of Cerebral Gliomas With FET & FCH PET/CT, and Magnetic Resonance Imaging/Spectroscopy
An observational study of Glioma, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The aim of this study is to establish the diagnostic value of O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) PET-CT, [18F]-fluorocholine (FCH) and magnetic resonance imaging (MRI) combined with magnetic resonance spectroscopy (MRS) in patients with suspected cerebral glioma using neuronavigated biopsies with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- How many people
- 51 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2009to Jan 2016
- 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 glioma suspicion referred for biopsy to our university hospital
Who may be able to join
- Suspicion of intracerebral glioma on MR
- Men of women
- Age >18, no upper limit as long as a biopsy or intervention is foreseen
Who cannot join
- Need of rapid intervention in <2 weeks
- Previous neurosurgical intervention (biopsy, shunt, etc.) or any other cerebral treatment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, CH, 1011
About this study
Official title: Impact of Multimodal Diagnostic Assessment of Cerebral Gliomas With F-18-fluoroethyl-L-tyrosine PET/CT, F-18-fluorocholine PET/CT and Magnetic Resonance Imaging and Spectroscopy
The aim of this study is to establish the diagnostic value of O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) PET-CT, [18F]-fluorocholine (FCH) and magnetic resonance imaging (MRI) combined with magnetic resonance spectroscopy (MRS) in patients with suspected cerebral glioma using neuronavigated biopsies with histopathological analysis as reference.
Read the detailed description
The objectives of the study are:
- To demonstrate if the multimodal approach, combining the morphological aspect of the MRI with the metabolic aspect of the tumor with magnetic resonance spectroscopy (MRS) and O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) or 18F]-fluorocholine (FCH) PET/CTthe FCH allows to improve the location of a active metabolic tumor and its impact on the ideal choice of sampling biopsy.
- To underline the differences and similarities between MRS and 18F]-fluorocholine PET / CT in the assessment of metabolism of the choline. To establish the diagnosis value of both methods, separately and in combination.
- To determine which examinations are useful and complementary for the diagnosis and the management of gliomes.
FET combined with MRS may be a powerful, widely applicable new method to improve the diagnosis of cerebral gliomas. The extent to which FCH and MRS provide similar information is not known precisely and this study will establish their respective diagnostic value in differentiating tumoral from non-tumoral tissue.
- Conditions
- Glioma
- Keywords
- Glioma, diagnosis, Imaging, Positron emission tomography, Magnetic resonance imaging, Magnetic resonance spectroscopy
- Medical subject headings
- Glioma, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of image-guided biopsy using FET, FCH PET/CT and MRS information to target the most representative sites of tumor grade as compared to histopathological examination
Measured: On the biopsy day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Lionel Perrier Foundation (Montreux, Switzerland)
- Responsible party
- Principal investigator, John O. Prior, University of Lausanne Hospitals
- Investigators
- John O Prior, PhD MD, Principal investigator, Centre Hospitalier Universitaire Vaudois and University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939315
- Sponsor's protocol ID
- 196/08
- Other IDs
- Swissmedic 2009DR3123
- Acronym
- Gliomes-FLP
- Status last verified
- Jan 2016
- First submitted
- 14 Jul 2009
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multimodal Diagnostic Assessment of Cerebral Gliomas With F-18-fluoroethyl-L-tyrosine PET/CT, F-18-fluorocholine PET/CT and Magnetic Resonance Imaging and Spectroscopy
- ClinicalTrials.gov ID
- NCT00939315
- Acronym / sponsor ID
- Gliomes-FLP / 196/08
- Conditions
- Glioma
- Keywords
- Glioma, diagnosis, Imaging, Positron emission tomography, Magnetic resonance imaging, Magnetic resonance spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- Lionel Perrier Foundation (Montreux, Switzerland)
- Study start
- Jul 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Jul 2009 (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 this study is to establish the diagnostic value of O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) PET-CT, [18F]-fluorocholine (FCH) and magnetic resonance imaging (MRI) combined with magnetic resonance spectroscopy (MRS) in patients with suspected cerebral glioma using neuronavigated biopsies with histopathological analysis as reference.
Detailed description
The objectives of the study are:
- To demonstrate if the multimodal approach, combining the morphological aspect of the MRI with the metabolic aspect of the tumor with magnetic resonance spectroscopy (MRS) and O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) or 18F]-fluorocholine (FCH) PET/CTthe FCH allows to improve the location of a active metabolic tumor and its impact on the ideal choice of sampling biopsy.
- To underline the differences and similarities between MRS and 18F]-fluorocholine PET / CT in the assessment of metabolism of the choline. To establish the diagnosis value of both methods, separately and in combination.
- To determine which examinations are useful and complementary for the diagnosis and the management of gliomes.
FET combined with MRS may be a powerful, widely applicable new method to improve the diagnosis of cerebral gliomas. The extent to which FCH and MRS provide similar information is not known precisely and this study will establish their respective diagnostic value in differentiating tumoral from non-tumoral tissue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with glioma suspicion referred for biopsy to our university hospital
Key inclusion criteria (3 listed)
- Suspicion of intracerebral glioma on MR
- Men of women
- Age >18, no upper limit as long as a biopsy or intervention is foreseen
Key exclusion criteria (2 listed)
- Need of rapid intervention in <2 weeks
- Previous neurosurgical intervention (biopsy, shunt, etc.) or any other cerebral treatment
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
Ability of image-guided biopsy using FET, FCH PET/CT and MRS information to target the most representative sites of tumor grade as compared to histopathological examination
Time frame: On the biopsy day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Individual participant dataSharing planned: No
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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.
John O Prior, PhD MD principal investigator
Centre Hospitalier Universitaire Vaudois and University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ability of image-guided biopsy using FET, FCH PET/CT and MRS information to target the most representative sites of tumor grade as compared to histopathological examination (time frame: On the biopsy day). 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 26 Jan 2016.