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

Glioma Clinical Trial

— PIGMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04738110
• Other study ID #: KCH20-139
• Status: Recruiting
• Start date: July 20, 2020
• Est. completion date: December 16, 2022

Study information

• Verified date: March 2022
• Source: King's College Hospital NHS Trust
• Contact: Thomas Booth
• Phone: 02032994828
• Email: thomasbooth[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma

Intervention

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

Locations

Country	Name	City	State
United Kingdom	King´s College Hospital NHS Foundation trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine how MR imaging influences the management of HGG patients		12 months
Secondary	Determine how advanced MR imaging influences the management of HGG patients		12 months