PET-MRI in Paediatric Brain Tumours (PET-MRI)
Primary Purpose
Brain Tumor, Pediatric
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET-MRI
Sponsored by
About this trial
This is an interventional other trial for Brain Tumor, Pediatric focused on measuring Brain Tumor, children, PET, MRI
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (PET-MRI)
Arm Description
Patients will undergo PET-MRI
Outcomes
Primary Outcome Measures
Primary outcome
Explore whether it is possible to recruit and scan children for post-treatment surveillance of brain tumours using PET-MRI in Sheffield in our centre
Secondary Outcome Measures
Acceptability
Are the study design, procedures, and intervention appropriate from the perspective of the participants?
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.
Full Information
NCT ID
NCT05553899
First Posted
September 21, 2022
Last Updated
September 21, 2022
Sponsor
Sheffield Children's NHS Foundation Trust
Collaborators
GE Healthcare, University of Sheffield
1. Study Identification
Unique Protocol Identification Number
NCT05553899
Brief Title
PET-MRI in Paediatric Brain Tumours
Acronym
PET-MRI
Official Title
Utility of PET-MRI in Post-treatment Surveillance of Paediatric Brain Tumours: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust
Collaborators
GE Healthcare, University of Sheffield
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Pediatric
Keywords
Brain Tumor, children, PET, MRI
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (PET-MRI)
Arm Type
Experimental
Arm Description
Patients will undergo PET-MRI
Intervention Type
Radiation
Intervention Name(s)
PET-MRI
Intervention Description
magnetic resonance imaging with positron emission tomography scanning using the tracer 18F-FDG
Primary Outcome Measure Information:
Title
Primary outcome
Description
Explore whether it is possible to recruit and scan children for post-treatment surveillance of brain tumours using PET-MRI in Sheffield in our centre
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Acceptability
Description
Are the study design, procedures, and intervention appropriate from the perspective of the participants?
Time Frame
1 year
Title
Accuracy
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David King, MBChB
Phone
0114 2717354
Email
d.king6@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Keith Pugh, PhD
Phone
0114 2717354
Email
keith.pugh1@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola Rominyi, MBChB
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PET-MRI in Paediatric Brain Tumours
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