Chers collègues et amis
vous trouverez ci dessous un appel à projet PHRC-K de Jacques DARCOURT. Si ce projet vous intéresse, merci de contacter directement Jacques DARCOURT pour lui faire part de votre souhait de participer.
bien amicalement O. Couturier pour le groupe Onco de la SFMN
Lettre d’intention
POSEIDON 01 : Etude de l’apport de l’imagerie par tomographie d’émission de positons à la 18F-FDOPA dans la proposition thérapeutique en réunion de concertation pluridisciplinaire de neuro-oncologie. |
POSEIDON 01: To investigate the impact of positron emission imaging using 18F-FDOPA in neuro-oncology on therapeutic proposal during multidisciplinary case review meeting. |
GENERAL INFORMATION
First name and name of coordinator : |
Jacques Darcourt |
Service ou département - Unit or department |
Nuclear Medicine |
Name and adress of the hospital |
Centre Antoine Lacassagne |
Phone number |
04 92 03 11 47 |
|
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|
Physician, dental practitioner / Biologist / Nurse, other paramedical : |
Physician |
Affiliated institution responsible for the budget from ministry of health |
Centre Antoine LACASSAGNE |
Anticipated number of recruiting centers (NC) |
6 |
Approximate level of funding required (K euros): |
185 K euros |
|
Co-investigators (1 à n) |
|||||||
N° |
Name |
Firstname |
Town |
Country |
Hospital |
|
Tel |
Speciality |
1 |
Dr BOURG |
Véronique |
NICE |
France |
CHU de Nice Hopital Pasteur Service de Neurologie 30, avenue de la Voie Romaine |
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|
04.92.03.84.50 |
Neurology |
2 |
Dr DE VERBIZIER LONJON
Pr DUFFAU |
Delphine
Hugues |
34295 Montpellier cedex 5 |
France |
CHU de Montpellier Hopital Lapeyronie Medecine Nucleaire 191 Avenue Du Doyen Gaston Giraud |
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04 67 33 84 64 |
Nuclear Medecine
Neuro-surgery |
3 |
Dr GUEDJ
Pr CHINOT |
Eric
Olivier |
13385 Marseille |
France |
Hôpital de la Timone Service Médecine Nucléaire
|
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04 91 96 85 27 |
Nuclear Medecine
Neuro-surgery |
4 |
Dr MONTRAVERS
Pr SCHLIENGER |
Françoise
Michel |
75020 Paris |
France |
Hôpital TENON Service Médecine Nucléaire 4, rue de la Chine |
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01 56 01 73 26 |
Nuclear Medecine
Radiation therapy |
5 |
Dr COLLOMBIER
Dr CAMPELLO |
Laurent
Chantal |
30000 Nîmes |
|
CHU de Nîmes Service Médecine Nucléaire Place du Pr R. Debré |
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04 66 68 32 44 |
Nuclear Medecine
Neuro-surgery |
RESEARCH PROJECT
Secondary objectives (detail, max 160 words) |
1- Measure the changes in the confidence level induced by 18F-FDOPA PET results when the treatment proposal is not changed. 2- Measure the impact of 18F-FDOPA PET results in the different clinical situations: recurrence vs pseudoprogression; bevacizumab efficacy evaluation (progression vs pseudoresponse). 3- Validate the 18F-FDOPA PET- induced modification of management (pathology when available, follow-up if not).
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Primary end point (linked with the main objective) |
Percentage of changes in RCP decisions induced by 18F-FDOPA PET results. |
Secondary end points (linked with the secondary objectives) |
1- In patients in whom the management is not changed: percentage of variation of confidence level in the decision induced by 18F-FDOPA PET results (decreased, unchanged, increased). 2- Percentages of changes induced by 18F-FDOPA PET results in the different clinical situations. 3- Sensitivity, specificity, PPV and NPV of 18F-FDOPA PET results for the diagnosis of recurrence and/or progression. |
Study population |
Main inclusion and exclusion criteria Patients diagnosed with high-grade glioma whose case is presented to the neuro-oncology RCP during the follow-up after the initial treatment in the following situations: - Patient has been informed and has signed the informed consent of the study |
NCLUSIONS
Duration of participation of each patient (days/months/years): |
Maximum of 9 months. |
Anticipated duration of recruitment (DUR) (in months): |
24 months. |
Total number of scheduled patients / observations to be recruited (NP) (3 digits + Justification of sample size max 80 words): |
150 patients should be included. This number is based on the assumption of a 30% change in management’s decision with a confidence interval of +/- 7.5 (formula: P+-2*√(PQ/n) which leads to 144 patients. This number is increased to 150 considering a 5% loss. The choice of 30% is a conservative hypothesis considering the percentage of 41% published by the UCLA group (Walter et al. JNM 2012) and a local pilot study on 31 patients showing 38.5% of changes. |
Number of patients / observations to be recruited / month / center ((NP/DUR)/NC) (2 digits + Justification if more than 2 patients/month/center) |
Details of the study population treated in each center, according to the active file of each hospital: Team 1 : Centre Lacassagne + CHU Nice : 20 patients/year Team 2 : CHU Montpellier : 15 patients/year Team 3 : HPHM Hal Timone : 25 patients/year Team 4 : HPAP Hal Tenon : 20 patients/year Team 5 : CHU Nimes : 30 patients/year The potential recruitment of each center, according to these data, is between 15 to 30 per year. Recruitment will be competitive. So, in conclusion, we can expect an average of 12 patients/observations by month that is an average of 2 patients/observations by center. |
Expected number of patients eligible in the centers |
||||||
N° |
Name |
Surname |
Town |
Country |
Expected recruitment/month |
Total |
1 |
Pr DARCOURT |
Jacques |
Nice |
France |
1-2 |
40
|
2 |
Dr DE VERBIZIER LONJON |
Delphine |
Montpellier |
France |
1-2 |
30 |
3 |
Dr GUEDJ |
Eric |
Marseille |
France |
1-2 |
40 |
4 |
Dr MONTRAVERS |
Françoise |
Paris |
France |
1 |
24 |
5 |
Dr COLLOMBIER
|
Laurent |
Nîmes |
France |
2 |
48
|
|
Others aspects to insure the feasibility of the project (Detail max 64 words) |
Preliminarily monocentric results have been obtained and presented on 16 patients (Role of 18F-DOPA in the follow-up of brain tumours: first results. J. Darcourt et al. oral presentation at the European Conference on Clinical Neuroimaging Lille 2013). Participating centers have experience in nuclear medicine in neurooncology and/or in 18F-FDOPA TEP. 18F-DOPA has marketing authorization in France. Multidisciplinary neuro-oncology boards (RCP; Réunions de Concertation Pluridisciplinaire) are well structured.
|
Expected patient or public health benefit (Detail max 320 words) |
High grade gliomas are the most common and aggressive brain tumours. The current treatments involving combinations of surgery, radiation, radiosurgery and chemotherapy have improved the overall survival of patients during the last decade (Lawrence et al Improving prognosis of glioblastoma in the 21st century: who has benefited most? Cancer 2012). Nevertheless, due to tumour recurrence, the median survival time is still limited to approximately 15 months. In order to try to prolong the survival time on individual patients basis, multidisciplinary neuro-oncology boards (RCP; Réunions de Concertation Pluridisciplinaire) need precise diagnoses of recurrence. This is a challenging issue due the possible confounding effects of the treatments themselves (radiation necrosis and pseudoresponse). Multi-modality MR imaging (gadolinium enhancement, FLAIR sequences, proton spectroscopy, perfusion …) is constantly making progresses. Amino-acids PET imaging is a promising technique in that context (Herholz K, Langen KJ, Schiepers C, Mountz JM. Brain tumors. Semin Nucl Med 2012). Multi-modality MR imaging and PET imaging need to be incorporated into routine post-treatment evaluation in order to improve the distinction between recurrence and treatment effects (Yang I, Aghi MK. New advances that enable identification of glioblastoma recurrence. Nat Rev Clin Oncol. 2009). 18F-FDOPA is the only 18F labelled amino-acid currently authorized in France. However, 18F-FDOPA PET remains an expensive technique and its practical usefulness in the RCP management context needs to be specifically evaluated. The identification of the situations in which 18F-DOPA brings added value (if any) will be useful to establish better diagnostic algorithms to improve personalized care in those patients. |