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出境医 / 临床实验 / Feasibility of 11C-MET PET/MRI Imaging in Pediatric Brain Fossa Tumors (TI-TFCE)

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

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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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 : November 3, 2019
Estimated Primary Completion Date : May 18, 2021
Estimated Study Completion Date : May 18, 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).
Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

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 Recruiting
Bron, France
Contact: Pierre-Aurélien BEURIAT       pierre-aurélien.beuriat@chu-lyon.fr   
Principal Investigator: Pierre-Aurélien BEURIAT, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Pierre-Aurélien BEURIAT, MD Hospices Civils de Lyon
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE November 3, 2019
Estimated Primary Completion Date May 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • number of patients who performed the PET/MRI [ Time Frame: 7 days ]
  • number of patients called in for PET/MRI who have not realized the PET/MRI [ Time Frame: 7 days ]
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of 11C-MET PET/MRI Imaging in Pediatric Brain Fossa Tumors
Official Title  ICMJE Pilot Study to Evaluate the Feasibility of Hybrid Brain Imaging 11C-MET PET/MRI of Posterior Brain Fossa Tumors in Children
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Posterior Brain Fossa Tumors in Children
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: 11C-MET PET/MRI
Intervention: Procedure: 11C-MET PET/MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 18, 2021
Estimated Primary Completion Date May 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977896
Other Study ID Numbers  ICMJE 69HCL18_0867
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierre-Aurélien BEURIAT, MD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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