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

NCT ID: NCT04738110

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-20

Study Completion Date

2022-12-16

Brief Summary

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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

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Conditions

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Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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KCH patients

75 high grade glioma patients from KCH

MRI

Intervention Type OTHER

Structural MR (T2, FLAIR, T1 and T1+C), DCE, DSC

NHNN patients

75 high grade glioma patients from NHNN

MRI

Intervention Type OTHER

Structural MR (T2, FLAIR, T1 and T1+C), DCE, DSC

Interventions

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MRI

Structural MR (T2, FLAIR, T1 and T1+C), DCE, DSC

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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King“s College Hospital NHS Foundation trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Thomas Booth

Role: CONTACT

02032994828

Facility Contacts

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Thomas Booth

Role: primary

Other Identifiers

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KCH20-139

Identifier Type: -

Identifier Source: org_study_id

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