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

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ClinicalTrials.gov Identifier: NCT03977896
Recruitment Status : Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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).





Primary Outcome Measures :
  1. number of patients who performed the PET/MRI [ Time Frame: 7 days ]
  2. number of patients called in for PET/MRI who have not realized the PET/MRI [ Time Frame: 7 days ]
  3. number of patients with good quality of the imaging [ Time Frame: 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



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977896


Contacts
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Contact: Pierre-Aurélien BEURIAT, MD 4 27 85 62 20 ext +33 pierre-aurélien.beuriat@chu-lyon.fr
Contact: Valérie LAUDY valerie.laudy@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant - Service de Neurochirurgie Pédiatrique Not yet recruiting
Bron, France
Contact: Pierre-Aurélien BEURIAT       pierre-aurélien.beuriat@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Pierre-Aurélien BEURIAT, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03977896     History of Changes
Other Study ID Numbers: 69HCL18_0867
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
PET/MRI
11C-MET
posterior brain fossa tumors
children
surgery
feasibility