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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT03977896

Collaborator

(none)

Enrollment

Location

Arm

24.2

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posterior Brain Fossa Tumors in Children	Procedure: 11C-MET PET/MRI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 3, 2019

Actual Primary Completion Date :

Nov 8, 2021

Actual Study Completion Date :

Nov 8, 2021

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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 [7 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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