Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics

NCT05512403 | Recruiting Phase 3

• 1 other identifier: 2020PI126
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Glioma

Outcome Measures

Primary Outcomes (1)

• To assess diagnostic performances of 18F-FDOPA PET (Positon Emission Tomography) Time-To-Peak in suspected LGGs without MRI -contrast enhancement for characterisation of aggressive lesions

  the sensitivity, specificity, predictive positive value (PPV) and negative predictive value (NPV) of the 18F-FDOPA kinetic TTP parameter, to characterise aggressive lesions within suspected LGGs with no contrast enhancement on MRI at the initial diagnosis.

  24 months

Secondary Outcomes (4)

• To assess the diagnostic performances of 18F-FDOPA "slope", to characterise aggressive lesions

  24 months

• To assess the diagnostic performances of 18F-FDOPA SUV static conventional parameters and/or radiomics analyses associated with TTP kinetic parameter, to characterise aggressive lesions

  24 months

• To assess, in patients suspected to have a non-contrast enhanced glioma at diagnosis the prevalence of aggressive forms within the suspected LGGs without any MRI contrast

  24 months

• To assess, in patients suspected to have a non-contrast enhanced glioma at diagnosis the clinical impact of the 18F-FDOPA PET (positon emission tomography) Time-To-Peak parameter

  24 months

Study Arms (1)

Patients with Low Grade Glioma (LGG) without any MRI contrast enhancement

EXPERIMENTAL

Patients presenting with brain lesions that lack contrast enhancement on MRI, that are suspected to be LGGs and that are referred for biopsy or surgery within the following 6 months will be eligible for the study. The initial MRI should be performed a maximum of 3 weeks before patient inclusion and should at least include the conventional morphological sequences (T1, T1 sequences with injection of contrast product and T2 FLAIR). Patients will be selected in a neuro-oncological multidisciplinary consultation meeting.

Drug: PET/CT with 18F-DOPA

Interventions

PET/CT with 18F-DOPA DRUG

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

Patients with Low Grade Glioma (LGG) without any MRI contrast enhancement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years old
• WHO general condition ≤2
• Identification of a unifocal brain tumour at the initial diagnosis with no contrast in the MRI and suspected to be a LGG, with biopsy/surgery envisaged within 6 months of the PET scan
• Subject affiliated to or beneficiary of a social security plan
• Subject having received complete information on the organisation of the research and having signed the informed consent form.

You may not qualify if:

• Multifocal brain lesions
• Contraindication to 18F-FDOPA PET
• Pregnant, parturient women or nursing mothers under Article L1121-5
• Women of childbearing age who do not have effective contraception under Article L1121-5
• Monitoring not possible
• Persons deprived of their liberty by a judicial or administrative decision under Article 1121-8, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.
• Patients cannot simultaneously participate in an interventional research trial for the duration of the KING study

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

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

Study Officials

• Antoine VERGER, MD, PhD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

• Aurélie KAS, MD, PhD

  APHP salpêtrière PARIS

  PRINCIPAL INVESTIGATOR

• Eric GUEDJ, MD,PhD

  APHM Marseille

  PRINCIPAL INVESTIGATOR

• Caroline BUND, MD

  Institut de cancérologie Strasbourg Europe

  PRINCIPAL INVESTIGATOR

• Florence LEJEUNE, MD, PhD

  Eugène MARQUIS Nantes

  PRINCIPAL INVESTIGATOR

• Anthelme FLAUS, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Nicolas De LEIRIS, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• Solène QUERELLOU, MD

  CHRU de Brest

  PRINCIPAL INVESTIGATOR

• Laurent COLLOMBIER, MD

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

• Maria RIBEIRO, MD, PhD

  CHU de Tours

  PRINCIPAL INVESTIGATOR

• Franck SEMAH, MD, PhD

  CHU de Lille

  PRINCIPAL INVESTIGATOR

• Merwan GINET, MD

  CHR Metz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VERONIQUE ROCH, MSc

CONTACT

0383154276; v.roch@chru-nancy.fr

ANTOINE VERGER, MD, PhD

CONTACT

0383155567; a.verger@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Patients presenting with brain lesions that lack contrast enhancement on MRI, that are suspected to be LGGs and that are referred for biopsy or surgery within the following 6 months will be eligible for the study.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 23, 2022
• Study Start: June 13, 2023
• Primary Completion: December 12, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)