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

Sponsor
King's College Hospital NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT04738110
Collaborator
(none)
150
Enrollment
1
Location
28.9
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: MRI

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Post-operative Imaging in High Grade Glioma: is Management Influenced?
Actual Study Start Date :
Jul 20, 2020
Anticipated Primary Completion Date :
Dec 16, 2022
Anticipated Study Completion Date :
Dec 16, 2022

Arms and Interventions

ArmIntervention/Treatment
KCH patients

75 high grade glioma patients from KCH

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

NHNN patients

75 high grade glioma patients from NHNN

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

Outcome Measures

Primary Outcome Measures

  1. Determine how MR imaging influences the management of HGG patients [12 months]

Secondary Outcome Measures

  1. Determine how advanced MR imaging influences the management of HGG patients [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1King´s College Hospital NHS Foundation trustLondonUnited KingdomSE5 9RS

Sponsors and Collaborators

  • King's College Hospital NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT04738110
Other Study ID Numbers:
  • KCH20-139
First Posted:
Feb 4, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022