Brain Tumor, PediatricPET-MRINCT05553899
Utility of PET-MRI in Surveillance of Paediatric Brain Tumours
A study testing PET-MRI in people with Brain Tumor, Pediatric, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a pilot project to explore the utility of PET-MRI in the post-treatment surveillance of high-grade gliomas or medulloblastomas in children in our institution. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Brain Tumor, Pediatric
- What is being tested?
- PET-MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have a presumptive or histologically confirmed diagnosis of a malignant brain tumour requiring treatment
- Diagnostic uncertainty about tumour recurrence post-treatment based on conventional MR imaging in the opinion of the MDT
- Have a life expectancy of at least three months
- Able to comply with an MRI scan without a general anaesthetic
Who cannot join
- Unable to comply with an MRI scan without a general anaesthetic
- Diabetes or other causes of hyperglycaemia
- Pregnancy
- Patient body habitus above scanner dimensions
- Standard contra-indication to MRI (eg. pacemaker, non-compatible metallic implants, altered renal function)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Children's Hospital
Sheffield, South Yorkshire, S10 1SN
Keith Pugh
About this study
Official title: Utility of PET-MRI in Post-treatment Surveillance of Paediatric Brain Tumours: a Pilot Study
This is a pilot project to explore the utility of PET-MRI in the post-treatment surveillance of high-grade gliomas or medulloblastomas in children in our institution.
Read the detailed description
Brain tumours are the most common solid tumours and the leading cause of death from cancer in children. A particular challenge in their management is detection of recurrent, residual or progressive tumour after initial treatment. This is typically detected on conventional MR surveillance scans. However, it is well documented that post-therapeutic changes can occur on MRI which may not represent disease, particularly after radiotherapy. Erroneously interpreting treatment-related changes as tumor progression may lead to the cessation of an effective treatment or the overestimation of the efficacy of a subsequent treatment. This is particularly important when assessing novel therapies in the context of early-phase clinical trials. A more accurate, non-invasive method of monitoring children after treatment for brain tumours could therefore enhance clinical management and may also lead to a more accurate assessment of novel therapies.
Hybrid Positron emission tomography-magnetic resonance imaging (PET/MRI) combines the high contrast and morphological resolution of MRI with the metabolic and physiological resolution from an intergrated PET scan. A variety of PET radiopharmaceutical tracers have been employed but 18F-fluodeoxyglucose (18F-FDG) has evolved over the last two decades to become the most important clinically. Increased glucose metabolism indicated by an increased FDG uptake is commonly seen in proliferating tumors due to the increased glucose transporter expression and the enzyme hexokinase, converting FDG to a phosphorylated product.
FDG-PET/CT has been demonstrated to have use for the differentiation of residual or recurrent tumours from post-therapeutic radiotherapy changes in adults 3-5 but its value in children is largely limited to case reports or small case series. The value of PET/MRI in paediatric in paediatric brain tumours is even less certain but in a series of 85 patients it was found to have a significant impact on management in the majority of cases. The accuracy of FDG PET in tumor surveillance may be higher than what has been historically reported because of improved spatial localization with concurrent use of MRI rather than CT.
This is a pilot project to explore the utility of PET-MRI in the post-treatment surveillance of high-grade gliomas or medulloblastomas in our institution. These tumours have the highest uptake of 18F-FDG and PET-MRI is therefore more likely to add diagnostic accuracy during their follow-up.
- Conditions
- Brain Tumor, Pediatric
- Being tested
- PET-MRI
- Keywords
- Brain Tumor, children, PET, MRI
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRIRadiation
magnetic resonance imaging with positron emission tomography scanning using the tracer 18F-FDG
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (PET-MRI) | Experimental | Patients will undergo PET-MRI Receives: Radiation: PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine number of patients able to recruited for study in one year
Determine feasibility of recruitment for study by measuring the number of patients able to recruited for study in one year
Measured: 1 year
Secondary outcomes (2)
Acceptability
Are the study design, procedures, and intervention appropriate from the perspective of the participants?
Measured: 1 year
Accuracy
determine the accuracy of FDG-PET vs MRI in determining residual tumour or tumour recurrence during post-treatment surveillance of high grade gliomas or medulloblastomas compared with biopsy results or clinical and radiological follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start28 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, PediatricStudies of the same condition, open and under way.
- 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare, University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Ola Rominyi, MBChB, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553899
- Sponsor's protocol ID
- SCH-2531
- Acronym
- PET-MRI
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of PET-MRI in Post-treatment Surveillance of Paediatric Brain Tumours: a Pilot Study
- ClinicalTrials.gov ID
- NCT05553899
- Acronym / sponsor ID
- PET-MRI / SCH-2531
- Conditions
- Brain Tumor, Pediatric
- Keywords
- Brain Tumor, children, PET, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- GE Healthcare, University of Sheffield
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Sep 2022 (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.
This is a pilot project to explore the utility of PET-MRI in the post-treatment surveillance of high-grade gliomas or medulloblastomas in children in our institution.
Detailed description
Brain tumours are the most common solid tumours and the leading cause of death from cancer in children. A particular challenge in their management is detection of recurrent, residual or progressive tumour after initial treatment. This is typically detected on conventional MR surveillance scans. However, it is well documented that post-therapeutic changes can occur on MRI which may not represent disease, particularly after radiotherapy. Erroneously interpreting treatment-related changes as tumor progression may lead to the cessation of an effective treatment or the overestimation of the efficacy of a subsequent treatment. This is particularly important when assessing novel therapies in the context of early-phase clinical trials. A more accurate, non-invasive method of monitoring children after treatment for brain tumours could therefore enhance clinical management and may also lead to a more accurate assessment of novel therapies.
Hybrid Positron emission tomography-magnetic resonance imaging (PET/MRI) combines the high contrast and morphological resolution of MRI with the metabolic and physiological resolution from an intergrated PET scan. A variety of PET radiopharmaceutical tracers have been employed but 18F-fluodeoxyglucose (18F-FDG) has evolved over the last two decades to become the most important clinically. Increased glucose metabolism indicated by an increased FDG uptake is commonly seen in proliferating tumors due to the increased glucose transporter expression and the enzyme hexokinase, converting FDG to a phosphorylated product.
FDG-PET/CT has been demonstrated to have use for the differentiation of residual or recurrent tumours from post-therapeutic radiotherapy changes in adults 3-5 but its value in children is largely limited to case reports or small case series. The value of PET/MRI in paediatric in paediatric brain tumours is even less certain but in a series of 85 patients it was found to have a significant impact on management in the majority of cases. The accuracy of FDG PET in tumor surveillance may be higher than what has been historically reported because of improved spatial localization with concurrent use of MRI rather than CT.
This is a pilot project to explore the utility of PET-MRI in the post-treatment surveillance of high-grade gliomas or medulloblastomas in our institution. These tumours have the highest uptake of 18F-FDG and PET-MRI is therefore more likely to add diagnostic accuracy during their follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (PET-MRI) | Experimental | Radiation: PET-MRIPatients will undergo PET-MRI |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Have a presumptive or histologically confirmed diagnosis of a malignant brain tumour requiring treatment
- Diagnostic uncertainty about tumour recurrence post-treatment based on conventional MR imaging in the opinion of the MDT
- Have a life expectancy of at least three months
- Able to comply with an MRI scan without a general anaesthetic
Key exclusion criteria (5 listed)
- Unable to comply with an MRI scan without a general anaesthetic
- Diabetes or other causes of hyperglycaemia
- Pregnancy
- Patient body habitus above scanner dimensions
- Standard contra-indication to MRI (eg. pacemaker, non-compatible metallic implants, altered renal function)
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 |
|---|---|---|
| PET-MRImagnetic resonance imaging with positron emission tomography scanning using the tracer 18F-FDG | Radiation | Diagnostic (PET-MRI) |
Primary outcome
Determine number of patients able to recruited for study in one year
Time frame: 1 year
Determine feasibility of recruitment for study by measuring the number of patients able to recruited for study in one year
2 secondary outcomes
Acceptability
Time frame: 1 year
Accuracy
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- 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.
Ola Rominyi, MBChB principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MRI in people with Brain Tumor, Pediatric, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 May 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David King, MBChB (0114 2717354, d.king6@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine number of patients able to recruited for study in one year (time frame: 1 year). 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 6 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.