Utility of PET-MRI in Surveillance of Paediatric Brain Tumours

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Utility of PET-MRI in Surveillance of Paediatric Brain Tumours

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	8 Years - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05553899
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sheffield Children's NHS Foundation Trust
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ola Rominyi, MBChB
Principal Investigator Affiliation	University of Sheffield
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor, Pediatric

Additional Details

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.

Arms & Interventions

Arms

Experimental: Diagnostic (PET-MRI)

Patients will undergo PET-MRI

Interventions

Radiation: - PET-MRI

magnetic resonance imaging with positron emission tomography scanning using the tracer 18F-FDG

Contact a Trial Team

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