Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics

NCT05512403 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-09-19

No results posted yet for this study

Summary

the investigators hypothesise that 18F-FDOPA PET kinetic parameters are good biomarkers to characterise suspected LGG brain lesions that exhibit no contrast on MRI, for identifying aggressive lesions. These parameters could constitute diagnostic biomarkers for this indication. This new diagnostic tool could enhance patient care in the short term in an evolving pathology affecting socially active subjects with a poor prognosis

Conditions

Interventions

DRUG

PET/CT with 18F-DOPA

A 18F-FDOPA PET exam is then performed (acquisition of 30 minutes in List Mode format) according to the French guidelines for PET neuro-oncological indications (Verger et al. Med Nuc, 2020, (5)). Patient preparation and acquisition: * 4 hours of fasting * No carbidopa premedication * 2 MBq / kg of 18F-FDOPA * Dynamic acquisition in List Mode format for 30 min starting simultaneously with the patient's injection * Low dose scanner for attenuation correction

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Antoine VERGER, MD, PhD · CHRU Nancy

  • Aurélie KAS, MD, PhD · APHP salpêtrière PARIS

  • Eric GUEDJ, MD,PhD · APHM Marseille

  • Caroline BUND, MD · Institut de cancérologie Strasbourg Europe

  • Florence LEJEUNE, MD, PhD · Eugène MARQUIS Nantes

  • Anthelme FLAUS, MD · Hospices Civils de Lyon

  • Nicolas De LEIRIS, MD · University Hospital, Grenoble

  • Solène QUERELLOU, MD · CHRU de Brest

  • Laurent COLLOMBIER, MD · CHU de Nimes

  • Maria RIBEIRO, MD, PhD · CHU de Tours

  • Franck SEMAH, MD, PhD · CHU de Lille

  • Merwan GINET, MD · CHR Metz

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2025-12-12
Completion
2026-10-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05512403 on ClinicalTrials.gov