GlioblastomaPOSEIDONNCT02631655
POSitron Emission Imaging Using 18F-FDOPA in Neurooncology
A study testing impact of device 18F-FDOPA PET on treatment decisions in people with Glioblastoma, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
18F-FDOPA PET is expensive. It is mandatory therefore to assess its impact on the management of patients with high-grade gliomas in order to provide medico-economic justification for its use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- impact of device 18F-FDOPA PET on treatment decisions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patient diagnosed with high-grade glioma
- Patient whose file has been submitted to the neurooncology MCC for follow-up after initial treatment and for whom there is a diagnostic doubt
- Age > 18 years
- Patient has been informed and has signed informed consent for the study
Who cannot join
- Patient presenting comorbidities or allergies on account of which MRI or 18F-FDOPA PET would be contraindicated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Impact of 18F-FDOPA Positon Emission Tomography on Therapeutic Proposals Made at Neurooncology Multidisciplinary Case Conferences
18F-FDOPA PET is expensive. It is mandatory therefore to assess its impact on the management of patients with high-grade gliomas in order to provide medico-economic justification for its use. The article by the UCLA group showed that 18F-FDOPA modified 41% of management decisions for patients with brain tumors (Walter JNM 2012). However, this study comprised 58 patients, combined primary and recurring tumors, and was based on questionnaires sent out to referring physicians. A targeted study is needed, therefore, to make a prospective multicenter assessment of the contribution of this technique in the context of high-grade glial tumors and neurooncology MCCs.
Read the detailed description
Current treatment of high-grade glioma combining surgery, radiotherapy and chemotherapy has enhanced overall survival during the past 10 years, notably thanks to the " Stupp " protocol using Temozolomide. At tumor evaluation and post-treatment follow-up, decisions regarding management (change, discontinuation or continuation of treatment) are discussed during multidisciplinary case conferences (MCC) between neurooncology specialists and are generally based primarily on MRI data. New treatment strategies are more effective on tumor tissue but also affect the adjacent healthy tissue. These phenomena give rise to complex MRI changes which can make it more difficult to perform differential diagnoses between tumor recurrence and treatment sequellae, such as radionecrosis and pseudoprogression. Alternatively, they can conceal effective tumor progression (appearance of pseudoresponse under antiangiogenics). Classical MRI interpretation criteria have evolved to take these phenomena into account (RANO criteria) and are now supplemented by new MRI data (perfusion and diffusion imaging, spectroscopy). Nonetheless, cases involving an uncertain recurrence diagnosis are still frequent. PET imaging has also shown very good results in differential diagnosis between posttreatment changes. Fluorodeoxyglucose-18-F (18FDG) can be used for glioma follow-up (Varrone EJNMMI 2009) but produces false positives during follow-up. In this setting, over-expression of amino acid transporter LAT-1 in brain tumors makes amino acids or marked analogs more suitable for PET imaging of glial tumors. C-11 methionine and 18F-FET can be used, but 18F-FDOPA is currently the only radiopharmaceutical agent to have received marketing authorization in France. Recently, the UCLA group demonstrated that 18F-FDOPA could modify the intended management of 41% of patients with brain tumors . The present projects aims to assess the impact of 18F-FDOPA PET imaging on decisions taken by neurooncology MCCs for the management of patients already treated for high-grade gliomas.
Expected benefits for patients and in terms of Public Health High-grade gliomas are the commonest and most aggressive brain tumors. Current therapy combining several treatments (surgery, radiotherapy, radiosurgery and chemotherapy) has improved overall patient survival during the past 10 years. Nevertheless, tumor recurrence accounts for a median survival of approximately only 15 months.
- Conditions
- Glioblastoma
- Being tested
- impact of device 18F-FDOPA PET on treatment decisions
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impact of device 18F-FDOPA PET on treatment decisionsOther
Imagery device: impact of 18F-FDOPA PET imaging on treatment decisions for patients with high-grade gliomas with an uncertain diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| device 18FDOPA | Other | impact of device 18F-FDOPA PET on treatment decisions Receives: Other: impact of device 18F-FDOPA PET on treatment decisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of modified therapeutic decisions connected to the data supplied by 18F-FDOPA PET
Measured: up to 3 years
Secondary outcomes (1)
Percentage of variation in the confidence level of diagnosis incorporating 18F-FDOPA PET findings (reduced, unchanged, increased).
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques DARCOURT, PHD, Study director, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631655
- Sponsor's protocol ID
- 2014/60
- Acronym
- POSEIDON
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2015
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Darcourt J, Chardin D, Bourg V, Gal J, Schiappa R, Blonski M, Koulibaly PM, Almairac F, Mondot L, Le Jeune F, Collombier L, Kas A, Taillandier L, Verger A. Added value of [18F]FDOPA PET to the management of high-grade glioma patients after their initial treatment: a prospective multicentre study. Eur J Nucl Med Mol Imaging. 2023 Jul;50(9):2727-2735. doi: 10.1007/s00259-023-06225-0. Epub 2023 Apr 22.
PubMed 37086272
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of 18F-FDOPA Positon Emission Tomography on Therapeutic Proposals Made at Neurooncology Multidisciplinary Case Conferences
- ClinicalTrials.gov ID
- NCT02631655
- Acronym / sponsor ID
- POSEIDON / 2014/60
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 16 Dec 2015 (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.
18F-FDOPA PET is expensive. It is mandatory therefore to assess its impact on the management of patients with high-grade gliomas in order to provide medico-economic justification for its use. The article by the UCLA group showed that 18F-FDOPA modified 41% of management decisions for patients with brain tumors (Walter JNM 2012). However, this study comprised 58 patients, combined primary and recurring tumors, and was based on questionnaires sent out to referring physicians. A targeted study is needed, therefore, to make a prospective multicenter assessment of the contribution of this technique in the context of high-grade glial tumors and neurooncology MCCs.
Detailed description
Current treatment of high-grade glioma combining surgery, radiotherapy and chemotherapy has enhanced overall survival during the past 10 years, notably thanks to the " Stupp " protocol using Temozolomide. At tumor evaluation and post-treatment follow-up, decisions regarding management (change, discontinuation or continuation of treatment) are discussed during multidisciplinary case conferences (MCC) between neurooncology specialists and are generally based primarily on MRI data. New treatment strategies are more effective on tumor tissue but also affect the adjacent healthy tissue. These phenomena give rise to complex MRI changes which can make it more difficult to perform differential diagnoses between tumor recurrence and treatment sequellae, such as radionecrosis and pseudoprogression. Alternatively, they can conceal effective tumor progression (appearance of pseudoresponse under antiangiogenics). Classical MRI interpretation criteria have evolved to take these phenomena into account (RANO criteria) and are now supplemented by new MRI data (perfusion and diffusion imaging, spectroscopy). Nonetheless, cases involving an uncertain recurrence diagnosis are still frequent. PET imaging has also shown very good results in differential diagnosis between posttreatment changes. Fluorodeoxyglucose-18-F (18FDG) can be used for glioma follow-up (Varrone EJNMMI 2009) but produces false positives during follow-up. In this setting, over-expression of amino acid transporter LAT-1 in brain tumors makes amino acids or marked analogs more suitable for PET imaging of glial tumors. C-11 methionine and 18F-FET can be used, but 18F-FDOPA is currently the only radiopharmaceutical agent to have received marketing authorization in France. Recently, the UCLA group demonstrated that 18F-FDOPA could modify the intended management of 41% of patients with brain tumors . The present projects aims to assess the impact of 18F-FDOPA PET imaging on decisions taken by neurooncology MCCs for the management of patients already treated for high-grade gliomas.
Expected benefits for patients and in terms of Public Health High-grade gliomas are the commonest and most aggressive brain tumors. Current therapy combining several treatments (surgery, radiotherapy, radiosurgery and chemotherapy) has improved overall patient survival during the past 10 years. Nevertheless, tumor recurrence accounts for a median survival of approximately only 15 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| device 18FDOPA | Other | Other: impact of device 18F-FDOPA PET on treatment decisionsimpact of device 18F-FDOPA PET on treatment decisions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient diagnosed with high-grade glioma
- Patient whose file has been submitted to the neurooncology MCC for follow-up after initial treatment and for whom there is a diagnostic doubt
- Age > 18 years
- Patient has been informed and has signed informed consent for the study
Key exclusion criteria (1 listed)
- Patient presenting comorbidities or allergies on account of which MRI or 18F-FDOPA PET would be contraindicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| impact of device 18F-FDOPA PET on treatment decisionsImagery device: impact of 18F-FDOPA PET imaging on treatment decisions for patients with high-grade gliomas with an uncertain diagnosis. | Other | device 18FDOPA |
Primary outcome
percentage of modified therapeutic decisions connected to the data supplied by 18F-FDOPA PET
Time frame: up to 3 years
1 secondary outcome
Percentage of variation in the confidence level of diagnosis incorporating 18F-FDOPA PET findings (reduced, unchanged, increased).
Time frame: up to 3 years
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 23 Apr 2026.
- Results publication: PubMed 37086272Darcourt J, Chardin D, Bourg V, Gal J, Schiappa R, Blonski M, Koulibaly PM, Almairac F, Mondot L, Le Jeune F, Collombier L, Kas A, Taillandier L, Verger A. Added value of [18F]FDOPA PET to the management of high-grade glioma patients after their initial treatment: a prospective multicentre study. Eur J Nucl Med Mol Imaging. 2023 Jul;50(9):2727-2735. doi: 10.1007/s00259-023-06225-0. Epub 2023 Apr 22.
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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.
Jacques DARCOURT, PHD study director
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing impact of device 18F-FDOPA PET on treatment decisions in people with Glioblastoma, run by Centre Antoine Lacassagne at 1 site in France.
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 4 inclusion and 1 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 23 Apr 2026. 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 France. 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?
percentage of modified therapeutic decisions connected to the data supplied by 18F-FDOPA PET (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631655, which also lists 1 linked publication.
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 23 Apr 2026.