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)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 28.9
• Patients Per Site Per Month: 5.2

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 Disease	Intervention/Treatment	Phase
Glioma	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	King´s College Hospital NHS Foundation trust	London		United Kingdom	SE5 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: Glioma

Study Results

No Results Posted as of Mar 31, 2022