- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05553899
Utility of PET-MRI in Surveillance of Paediatric Brain Tumours (PET-MRI)
Utility of PET-MRI in Post-treatment Surveillance of Paediatric Brain Tumours: a Pilot Study
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David King, MBChB
- Phone Number: 0114 2717354
- Email: d.king6@nhs.net
Study Contact Backup
- Name: Keith Pugh, PhD
- Phone Number: 0114 2717354
- Email: keith.pugh1@nhs.net
Study Locations
-
-
South Yorkshire
-
Sheffield, South Yorkshire, United Kingdom, S10 1SN
- Recruiting
- Sheffield Children's Hospital
-
Contact:
- Keith Pugh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic (PET-MRI)
Patients will undergo PET-MRI
|
magnetic resonance imaging with positron emission tomography scanning using the tracer 18F-FDG
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: 1 year
|
Are the study design, procedures, and intervention appropriate from the perspective of the participants?
|
1 year
|
|
Accuracy
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ola Rominyi, MBChB, University of Sheffield
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCH-2531
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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