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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
Sheffield Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brain Tumor, Pediatric focused on measuring Brain Tumor, children, PET, MRI

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 21, 2022
    Last Updated
    September 21, 2022
    Sponsor
    Sheffield Children's NHS Foundation Trust
    Collaborators
    GE Healthcare, University of Sheffield
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    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

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    PET-MRI in Paediatric Brain Tumours

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