Pediatric Brain TumorNCT06226519
Integrated PET/MRI and Germline Variants to Differentiate Brain Tumopr Recurrence From Iatrogenicchanges in Children
An observational study of Pediatric Brain Tumor, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Nuclear magnetic resonance imaging (NMR) is used in pediatric brain tumors for purposes of diagnosis, evaluation of response to treatments, and monitoring of patients in follow-up. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Brain Tumor
- What is being tested?
- 11C-MET-PET/RMN
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2020to 13 May 2024
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- Child, Adult
Study population: 60 children and/or adolescents (≤18 years) with a diagnosis of brain tumor (medulloblastoma, other embryonal tumors or high-grade gliomas), who have followed the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy and completed radiotherapy for at at least 6 months will undergo a brain MET-PET/MRI.
Who may be able to join
- children and/or adolescents (≤18 years) diagnosed with brain tumor.
- children who underwent the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy.
Who cannot join
- patients >18 years
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Irccs San Raffaele
Milan
Arturo Chiti, 0226432716, chiti.arturo@hsr.it
Alessandra Maielli, 0226433639, maielli.alessandra@hsr.it
About this study
Nuclear magnetic resonance imaging (NMR) is used in pediatric brain tumors for purposes of diagnosis, evaluation of response to treatments, and monitoring of patients in follow-up. Through conventional imaging techniques it remains difficult to differentiate tumor recurrence from pseudo-progression or other iatrogenic changes after radiotherapy or chemotherapy, but it remains a relevant and essential clinical need for patient management.
- Conditions
- Pediatric Brain Tumor
- Being tested
- 11C-MET-PET/RMN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-MET-PET/RMNDiagnostic test
60 children and/or adolescents (≤18 years) with a diagnosis of brain tumor (medulloblastoma, other embryonal tumors or high-grade gliomas), who have followed the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy and completed radiotherapy for at least 6 months will undergo a brain MET-PET/MRI.
What is being measured
The primary outcome is the main question the study is designed to answer.
MET-PET/brain MRI in children with brain tumor for diagnosis of brain tumor recurrence compared to therapy-induced changes.
The role of MET-PET/MRI and radiogenomics could play in the follow-up management of children and adolescents with brain tumors and in ensuring timely intervention in case of tumor recurrence/progression.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start13 May 2020
- Primary completion13 May 2024 (estimated)
- Study completion13 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Brain TumorStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226519
- Sponsor's protocol ID
- PET/RMN
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated PET/MRI and Germline Variants to Differentiate Brain Tumopr Recurrence From Iatrogenicchanges in Children
- ClinicalTrials.gov ID
- NCT06226519
- Acronym / sponsor ID
- PET/RMN
- Conditions
- Pediatric Brain Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- 13 May 2024 (estimated)
- Study completion
- 13 May 2024 (estimated)
- First posted
- 26 Jan 2024 (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.
Nuclear magnetic resonance imaging (NMR) is used in pediatric brain tumors for purposes of diagnosis, evaluation of response to treatments, and monitoring of patients in follow-up. Through conventional imaging techniques it remains difficult to differentiate tumor recurrence from pseudo-progression or other iatrogenic changes after radiotherapy or chemotherapy, but it remains a relevant and essential clinical need for patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 60 children and/or adolescents (≤18 years) with a diagnosis of brain tumor (medulloblastoma, other embryonal tumors or high-grade gliomas), who have followed the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy and completed radiotherapy for at at least 6 months will undergo a brain MET-PET/MRI.
Key inclusion criteria (2 listed)
- children and/or adolescents (≤18 years) diagnosed with brain tumor.
- children who underwent the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy.
Key exclusion criteria (1 listed)
- patients >18 years
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/RMN60 children and/or adolescents (≤18 years) with a diagnosis of brain tumor (medulloblastoma, other embryonal tumors or high-grade gliomas), who have followed the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy and completed radiotherapy for at least 6 months will undergo a brain MET-PET/MRI. | Diagnostic test | – |
Primary outcome
MET-PET/brain MRI in children with brain tumor for diagnosis of brain tumor recurrence compared to therapy-induced changes.
Time frame: 4 years
The role of MET-PET/MRI and radiogenomics could play in the follow-up management of children and adolescents with brain tumors and in ensuring timely intervention in case of tumor recurrence/progression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Brain Tumor, run by IRCCS San Raffaele at 1 site in Italy.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jan 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arturo Chiti (0226432716, chiti.arturo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MET-PET/brain MRI in children with brain tumor for diagnosis of brain tumor recurrence compared to therapy-induced changes. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2024.