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POSitron Emission Imaging Using 18F-FDOPA in Neurooncology (POSEIDON)

Primary Purpose

Glioblastoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
impact of device 18F-FDOPA PET on treatment decisions
Sponsored by
Centre Antoine Lacassagne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient presenting comorbidities or allergies on account of which MRI or 18F-FDOPA PET would be contraindicated.

Sites / Locations

  • Centre Antoine Lacassagne

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

device 18FDOPA

Arm Description

impact of device 18F-FDOPA PET on treatment decisions

Outcomes

Primary Outcome Measures

percentage of modified therapeutic decisions connected to the data supplied by 18F-FDOPA PET

Secondary Outcome Measures

Percentage of variation in the confidence level of diagnosis incorporating 18F-FDOPA PET findings (reduced, unchanged, increased).

Full Information

First Posted
December 5, 2015
Last Updated
February 15, 2021
Sponsor
Centre Antoine Lacassagne
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1. Study Identification

Unique Protocol Identification Number
NCT02631655
Brief Title
POSitron Emission Imaging Using 18F-FDOPA in Neurooncology
Acronym
POSEIDON
Official Title
Study of the Impact of 18F-FDOPA Positon Emission Tomography on Therapeutic Proposals Made at Neurooncology Multidisciplinary Case Conferences
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
device 18FDOPA
Arm Type
Other
Arm Description
impact of device 18F-FDOPA PET on treatment decisions
Intervention Type
Other
Intervention Name(s)
impact of device 18F-FDOPA PET on treatment decisions
Intervention Description
Imagery device: impact of 18F-FDOPA PET imaging on treatment decisions for patients with high-grade gliomas with an uncertain diagnosis.
Primary Outcome Measure Information:
Title
percentage of modified therapeutic decisions connected to the data supplied by 18F-FDOPA PET
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Percentage of variation in the confidence level of diagnosis incorporating 18F-FDOPA PET findings (reduced, unchanged, increased).
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patient presenting comorbidities or allergies on account of which MRI or 18F-FDOPA PET would be contraindicated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques DARCOURT, PHD
Organizational Affiliation
Centre Antoine Lacassagne
Official's Role
Study Director
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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POSitron Emission Imaging Using 18F-FDOPA in Neurooncology

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