Posterior Brain Fossa Tumors in ChildrenTI-TFCENCT03977896
Feasibility of 11C-MET PET/MRI Imaging in Pediatric Brain Fossa Tumors
A study testing 11C-MET PET/MRI in people with Posterior Brain Fossa Tumors in Children, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Posterior Brain Fossa Tumors in Children
- What is being tested?
- 11C-MET PET/MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2019to 8 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant - Service de Neurochirurgie Pédiatrique
Bron
About this study
Official title: 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.
Read more
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
- Being tested
- 11C-MET PET/MRI
- Keywords
- PET/MRI, 11C-MET, posterior brain fossa tumors, children, surgery, feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-MET PET/MRIProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 11C-MET PET/MRI | Experimental | Not described Receives: Procedure: 11C-MET PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who performed the PET/MRI
Measured: 7 days
number of patients called in for PET/MRI who have not realized the PET/MRI
Measured: 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start3 Nov 2019
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posterior Brain Fossa Tumors in ChildrenStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Aurélien BEURIAT, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977896
- Sponsor's protocol ID
- 69HCL18_0867
- Acronym
- TI-TFCE
- Status last verified
- Aug 2025
- First submitted
- 5 Jun 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38498623
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Feasibility of Hybrid Brain Imaging 11C-MET PET/MRI of Posterior Brain Fossa Tumors in Children
- ClinicalTrials.gov ID
- NCT03977896
- Acronym / sponsor ID
- TI-TFCE / 69HCL18_0867
- Conditions
- Posterior Brain Fossa Tumors in Children
- Keywords
- PET/MRI, 11C-MET, posterior brain fossa tumors, children, surgery, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Nov 2019 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 11C-MET PET/MRI | Experimental | Procedure: 11C-MET PET/MRI |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 11C-MET PET/MRIExcept 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). | Procedure or surgery | 11C-MET PET/MRI |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 38498623Beuriat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Aurélien BEURIAT, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 11C-MET PET/MRI in people with Posterior Brain Fossa Tumors in Children, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients who performed the PET/MRI (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03977896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.