Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics

Trial Title: Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics

NCT ID: NCT05512403

Condition: Glioma

Conditions: Official terms:
Glioma

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: 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.

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: PET/CT with 18F-DOPA
Description: 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
Arm group label: Patients with Low Grade Glioma (LGG) without any MRI contrast enhancement

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: CHRU Nancy

Address:
City: Vandoeuvre les Nancy cedex
Zip: 54511
Country: France

Status: Recruiting

Contact:
Last name: VERONIQUE ROCH, MSc
Email: v.roch@chru-nancy.fr

Start date: June 13, 2023

Completion date: October 30, 2026

Lead sponsor:
Agency: Central Hospital, Nancy, France
Agency class: Other

Source: Central Hospital, Nancy, France

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05512403