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Trial Title:
Utility of PET-MRI in Surveillance of Paediatric Brain Tumours
NCT ID:
NCT05553899
Condition:
Brain Tumor, Pediatric
Conditions: Official terms:
Brain Neoplasms
Conditions: Keywords:
Brain Tumor, children, PET, MRI
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
PET-MRI
Description:
magnetic resonance imaging with positron emission tomography scanning using the tracer
18F-FDG
Arm group label:
Diagnostic (PET-MRI)
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.
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.
Criteria for eligibility:
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)
Gender:
All
Minimum age:
8 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sheffield Children's Hospital
Address:
City:
Sheffield
Zip:
S10 1SN
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Keith Pugh
Start date:
February 28, 2024
Completion date:
March 2026
Lead sponsor:
Agency:
Sheffield Children's NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
GE Healthcare
Agency class:
Industry
Collaborator:
Agency:
University of Sheffield
Agency class:
Other
Source:
Sheffield Children's NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05553899