Feasibility of 11C-MET PET/MRI Imaging in Pediatric Brain Fossa Tumors

NCT ID: NCT03977896

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-03
• Study Completion Date: 2021-11-08

Brief Summary

Brain tumors are the most common solid tumors in children and are the second most common cause of cancer-related death among this population. Posterior brain fossa tumors represent about 50% of children brain tumors.

Recently, knowledge in molecular biology has permitted to identify different tumors subgroups of very different prognosis. Today, surgery removal of the tumor is the mandatory. Neuro-oncological treatment differs depending on the histological and molecular subgroup. With classical Magnetic Resonance Imaging (cMRI), distinction between different types of posterior fossa tumors remains difficult.

Positron Emission Tomography combined with MRI (PET/MRI) has proven its benefits for the management of brain tumors. The direct spatiotemporal correlation makes possible the assessment of metabolic, anatomical and functional information. PET/MRI would provide precisions on the pre-therapeutic characterization of tumors, which could permit to modify the patients' care.

L- [methyl-11C] methionine (11C-MET) is currently the gold-standard tracer used in neuro-oncology, but few data exists in children. 11C-MET PET/MRI assessment seems promising, but has not been studied enough. To the best of our knowledge, there is no specific study on primary brain tumors of the posterior fossa in children using 11C-MET PET/MRI.

The primary objectives of this first pilot study is to evaluate the practical feasibility of 11C-MET PET/MRI imaging (machine accessibility and imaging interpretability) before surgery in a population of children older than 5 years old with posterior fossa tumors.

The secondary objectives aim to describe :

• the PET/MRI parameters of the different tumors studied,
• and the patient's participation acceptation.

This feasibility study will allow us to standardize the PET/MRI measurements; this could allow us to discriminate, in a larger study, the different tumor subgroups before surgery.

Conditions

Posterior Brain Fossa Tumors in Children

Study Design

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

Study Groups

11C-MET PET/MRI

Group Type: EXPERIMENTAL

11C-MET PET/MRI

Intervention Type: PROCEDURE

Except PET/MRI imaging, all the examinations will be done according to the patient's usual care.

PET/MRI imaging will be realized within max 7 days after children enrollment, and the surgery (usual care) will be performed within max 4 days after PET/MRI imaging.

PET/MRI imaging will include the following sequences: T1axial, Diffusion, Magnetic susceptibility post-Gadolinium injection, 3DT1 pre and post-Gadolinium injection, and Arterial Spin Labelling Imaging (ASL).

Interventions

11C-MET PET/MRI

Except PET/MRI imaging, all the examinations will be done according to the patient's usual care.

PET/MRI imaging will be realized within max 7 days after children enrollment, and the surgery (usual care) will be performed within max 4 days after PET/MRI imaging.

PET/MRI imaging will include the following sequences: T1axial, Diffusion, Magnetic susceptibility post-Gadolinium injection, 3DT1 pre and post-Gadolinium injection, and Arterial Spin Labelling Imaging (ASL).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients ≥ 5 years old and < 18 years old at enrollment,
• with primary posterior brain fossa tumor, metastatic or not,
• hospitalized in the Department of Pediatric Neurosurgery of Femme-Mère-Enfant Hospital, and for whom a surgery is scheduled,
• covered by national health insurance,
• patient's parents or legal guardians who have provided written informed consent prior to participation in the study.

Exclusion Criteria

• Patients with contraindication for MRI (claustrophobia, carrying metallic object)
• Patients with contraindication for Gadolinium injection (including pregnancy and breastfeeding)
• patient with recurring posterior brain fossa tumor
• patient with brain stem infiltrative tumor

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Aurélien BEURIAT, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant - Service de Neurochirurgie Pédiatrique

Bron, , France

Countries

France

References

Beuriat PA, Flaus A, Portefaix A, Szathmari A, Janier M, Hermier M, Lorthois-Ninou S, Scheiber C, Isal S, Costes N, Merida I, Lancelot S, Vasiljevic A, Leblond P, Faure Conter C, Saunier C, Kassai B, Vinchon M, Di Rocco F, Mottolese C. Preoperative 11 C-Methionine PET-MRI in Pediatric Infratentorial Tumors. Clin Nucl Med. 2024 May 1;49(5):381-386. doi: 10.1097/RLU.0000000000005174. Epub 2024 Mar 15.

Reference Type: RESULT

PMID: 38498623 (View on PubMed)

Other Identifiers

69HCL18_0867

Identifier Type: -

Identifier Source: org_study_id