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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

David King, MBChB contact

0114 2717354

d.king6@nhs.net

Keith Pugh, PhD contact

0114 2717354

keith.pugh1@nhs.net

United Kingdom1 site, 1 recruiting
  • Sheffield Children's Hospital

    Sheffield, South Yorkshire, S10 1SN

    Keith Pugh

    Recruiting

Other trials in United Kingdom

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.

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 groups in NCT05553899
Study groupRoleWhat they receive
Diagnostic (PET-MRI)ExperimentalPatients 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.

  1. 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)
  1. Acceptability

    Are the study design, procedures, and intervention appropriate from the perspective of the participants?

    Measured: 1 year

  2. 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.

  1. First posted26 Sep 2022
  2. Study start28 Feb 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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)
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

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.

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