Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics

NCT ID: NCT05512403

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-13
• Study Completion Date: 2026-10-30

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

Detailed Description

Diffuse low-grade gliomas (LGGs) without any contrast enhancement on MRI are rare (15% of gliomas, 700 cases/year in France), have a poor prognosis (median overall survival from 5 to 15 years) and affect young, socially active subjects (median age 40 years). Among these lesions, 30% present with high grade histopathological criteria or with poor prognostic molecular characteristics, according to the 2021 WHO Classification of Tumors of the Central Nervous System (lack of IDH [Isocitrate DeHydrogenase] mutation, CDKN2A/B deletion). These high-grade types of tumours progress within 6 months and their diagnosis and management represent a public health issue. Moreover, the care of LGG patients is currently not standardised.

Although treatment is based on surgery and the complete excision of the lesion, as far as this is possible, and/or first-line chemotherapy ±radiotherapy, the optimal time to begin treatment remains controversial.

Aggressive forms should be diagnosed as soon as possible to allow immediate surgery to improve survival, whilst strategies allowing the maintenance of an optimal quality of life, more often with functional surgery alone, are recommended for non-aggressive forms. The main hurdle to standardised patient management is the lack of amenable non-invasive biomarkers to identify aggressive LGG forms.

18F-FDOPA positron emission tomography (PET) is promising to diagnose initial gliomas with conventional Standardised-Uptake-Value (SUV) parameters. Our team recently demonstrated the potential of 18F-FDOPA PET kinetics to better characterise gliomas. Two parameters are determined from the 30-minute dynamic acquisition curve of the tumour: the time-to-peak SUV (TTP), and the SUV slope. In our previous studies, limited by their monocentric and retrospective nature, molecular characteristics were mainly predicted by TTP: long TTP for an IDH-mutation and short TTP for IDH-wildtype tumours. A prospective multicentric study is needed to confirm our preliminary results in a specific population of suspected LGGs without any contrast enhancement on MRI.

The investigator hypothesise that 18F-FDOPA PET kinetic parameters are biomarkers which lead to improved care because they characterise aggressive forms of gliomas exhibiting no contrast on MRI.

Conditions

Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

PET/CT with 18F-DOPA

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• MRI performed a maximum of 3 weeks before inclusion and comprising the conventional morphological sequences (T1, T1 sequences with injection of contrast agent and T2 FLAIR).
• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Antoine VERGER

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antoine VERGER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Aurélie KAS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP salpêtrière PARIS

Eric GUEDJ, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

APHM Marseille

Caroline BUND, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de cancérologie Strasbourg Europe

Florence LEJEUNE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Eugène MARQUIS Nantes

Anthelme FLAUS, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Nicolas De LEIRIS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Solène QUERELLOU, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU de Brest

Laurent COLLOMBIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Maria RIBEIRO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Tours

Franck SEMAH, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Lille

Merwan GINET, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz

Locations

CHRU Nancy

Vandœuvre-lès-Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

VERONIQUE ROCH, MSc

Role: CONTACT

v.roch@chru-nancy.fr

0383154276 ext. +33

ANTOINE VERGER, MD, PhD

Role: CONTACT

a.verger@chru-nancy.fr

0383155567 ext. +33

Facility Contacts

VERONIQUE ROCH, MSc

Role: primary

v.roch@chru-nancy.fr

Other Identifiers

2020PI126

Identifier Type: -

Identifier Source: org_study_id