POSitron Emission Imaging Using 18F-FDOPA in Neurooncology

NCT02631655 | Completed

• 1 other identifier: 2014/60
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

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

  up to 3 years

Secondary Outcomes (1)

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

  up to 3 years

Study Arms (1)

device 18FDOPA

OTHER

impact of device 18F-FDOPA PET on treatment decisions

Other: impact of device 18F-FDOPA PET on treatment decisions

Interventions

impact of device 18F-FDOPA PET on treatment decisions OTHER

Imagery device: impact of 18F-FDOPA PET imaging on treatment decisions for patients with high-grade gliomas with an uncertain diagnosis.

device 18FDOPA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06000, France

Location

Related Publications (1)

• 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.

  PMID: 37086272 RESULT

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jacques DARCOURT, PHD

  Centre Antoine Lacassagne

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2015
• First Posted: December 16, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)