Feasibility of 11C-MET PET/MRI Imaging in Pediatric Brain Fossa Tumors (TI-TFCE)

Pilot Study to Evaluate the Feasibility of Hybrid Brain Imaging 11C-MET PET/MRI of Posterior Brain Fossa Tumors in Children

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.

Study Overview

• Status: Completed
• Conditions: Posterior Brain Fossa Tumors in Children
• Intervention / Treatment: Procedure: 11C-MET PET/MRI

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant - Service de Neurochirurgie Pédiatrique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 11C-MET PET/MRI

Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients who performed the PET/MRI		7 days
number of patients called in for PET/MRI who have not realized the PET/MRI		7 days
number of patients with good quality of the imaging	The interpretability of the imaging will be evaluated by a Review Committee (two pairs composed each by a radiologist (for MRI imaging) and a nuclear physician (for PET imaging)). The imaging will be classified under good or bad quality	7 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Pierre-Aurélien BEURIAT, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2019
• Primary Completion (Actual): November 8, 2021
• Study Completion (Actual): November 8, 2021

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: surgery; children; feasibility; PET/MRI; 11C-MET; posterior brain fossa tumors
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Carbon-11 methionine
• Other Study ID Numbers: 69HCL18_0867

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No