NCT05553899

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Feb 2024Jun 2027

First Submitted

Initial submission to the registry

September 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 28, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 6, 2026

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

September 21, 2022

Last Update Submit

April 29, 2026

Conditions

Keywords

Brain Tumor, children, PET, MRI

Outcome Measures

Primary Outcomes (1)

  • Determine number of patients able to recruited for study in one year

    Determine feasibility of recruitment for study by measuring the number of patients able to recruited for study in one year

    1 year

Secondary Outcomes (2)

  • Acceptability

    1 year

  • Accuracy

    1 year

Study Arms (1)

Diagnostic (PET-MRI)

EXPERIMENTAL

Patients will undergo PET-MRI

Radiation: PET-MRI

Interventions

PET-MRIRADIATION

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

Diagnostic (PET-MRI)

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Children's Hospital

Sheffield, South Yorkshire, S10 1SN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ola Rominyi, MBChB

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David King, MBChB

CONTACT

Keith Pugh, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 26, 2022

Study Start

February 28, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

May 6, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations