Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05512403
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Central Hospital, Nancy, France
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Antoine VERGER, MD, PhDAurélie KAS, MD, PhDEric GUEDJ, MD,PhDCaroline BUND, MDFlorence LEJEUNE, MD, PhDAnthelme FLAUS, MDNicolas De LEIRIS, MDSolène QUERELLOU, MDLaurent COLLOMBIER, MDMaria RIBEIRO, MD, PhDFranck SEMAH, MD, PhDMerwan GINET, MD
Principal Investigator Affiliation CHRU NancyAPHP salpêtrière PARISAPHM MarseilleInstitut de cancérologie Strasbourg EuropeEugène MARQUIS NantesHospices Civils de LyonUniversity Hospital, GrenobleCHRU de BrestCHU de NimesCHU de ToursCHU de LilleCHR Metz
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

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

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International Sites

CHRU Nancy, Vandoeuvre les Nancy cedex, France

Status

Recruiting

Address

CHRU Nancy

Vandoeuvre les Nancy cedex, , 54511

Site Contact

VERONIQUE ROCH, MSc

[email protected]

0383154276

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