Post-operative Imaging in High Grade Glioma: is Management Influenced?

• Conditions: Glioma
• Interventions: Other: MRI

• Registration Number: NCT04738110
• Lead Sponsor: King's College Hospital NHS Trust

Brief Summary

Magnetic resonance imaging (MRI) is likely to play an important role in the management of high grade glioma. Appropriate and timely neuroimaging in the follow up period is believed to be crucial in making subsequent management decisions. However, there is a paucity in the literature providing evidence to support this. The aim of this study is to determine whether neuroimaging performed at each component of the patient pathway after initial high grade glioma treatment, actually results in a real change in management (as opposed to a perceived change in management). The main emphasis is on all imaging used at the time of a MDM, however, we will also study specifically dynamic susceptibility contrast-enhanced (DSC) MRI and dynamic contrast enhanced (DCE) MRI.

The study is in the format of Mock MDMs to be compatible with real life decision making. Using retrospective identical information available at the MDM i.e. compiled recent correspondence, histopathological and molecular information, the MDM members (oncology nurse, oncologist, neurosurgeon, neuroradiologist, pathologist/molecular scientist) will prospectively determine the patient management with and without the imaging.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-20
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-04
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Histologically proven HGG patients (Grade III and IV WHO criteria)
• Underwent surgery, radiotherapy and chemotherapy regimen according to 2018 NICE guidelines (1)
• >=18 years old
• Has follow-up MRI imaging (T1, T2, FLAIR and T1 with contrast enhancement) and also DSC and DCE imaging
• Evaluated at MDT meetings between March 2018 and March 2020.

Exclusion Criteria

• Patients who have insufficient clinical and radiological follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NHNN patients	MRI	75 high grade glioma patients from NHNN
KCH patients	MRI	75 high grade glioma patients from KCH

Primary Outcome Measures

Name	Time	Method
Determine how MR imaging influences the management of HGG patients	12 months

Secondary Outcome Measures

Name	Time	Method
Determine how advanced MR imaging influences the management of HGG patients	12 months

Trial Locations

Locations (1)

King´s College Hospital NHS Foundation trust; 🇬🇧 London, United Kingdom