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

NCT04738110 | Unknown

• 1 other identifier: KCH20-139
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Determine how MR imaging influences the management of HGG patients

  12 months

Secondary Outcomes (1)

• Determine how advanced MR imaging influences the management of HGG patients

  12 months

Study Arms (2)

KCH patients

75 high grade glioma patients from KCH

Other: MRI

NHNN patients

75 high grade glioma patients from NHNN

Other: MRI

Interventions

MRI OTHER

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

KCH patients; NHNN patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HGG (Grade III and IV WHO criteria) patients discussed in MDTM between March 2018 and March 2020 at KCH and NHNN are being studied.

You may qualify if:

• 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.

You may not qualify if:

• Patients who have insufficient clinical and radiological follow-up

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King´s College Hospital NHS Foundation trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Thomas Booth

CONTACT

02032994828; thomasbooth@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: July 20, 2020
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)