Improving Treatment of Glioblastoma: Distinguishing Progression From Pseudoprogression
1 other identifier
observational
500
1 country
15
Brief Summary
Glioblastoma is the most aggressive kind of brain cancer and leads on average to 20 years of life lost, more than any other cancer. MRI images of the brain are taken before the operation, and every few months after treatment, to see if the cancer regrows. It can be hard for doctors to tell if what they see in these images represent growing cancer or a sideeffect of treatment. The similarity of the appearance of the treatment side-effects to cancer is confusing and is known as "pseudoprogression" (as opposed to true cancer progression). If doctors mistake the appearance of treatment side-effects for growing cancer, they may think that the treatment is failing and change the patient's treatment too early or put them into a clinical trial. This means that patients may not be given the full treatment and the results from some clinical trials cannot be trusted. The aim of this study is to provide doctors with a computer program that will use MRI images of the brain that are routinely obtained throughout treatment, in order to help them more accurately identify when the cancer regrows.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2019
CompletedFirst Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2025
CompletedApril 21, 2023
April 1, 2023
5.2 years
April 21, 2020
April 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of the artificial intelligence model
Defined by a confusion matrix of sensitivity and specificity to true positives and true negatives.
Up to 36 months
Secondary Outcomes (1)
Failure rate of the artificial intelligence model
Up to 36 months
Eligibility Criteria
Patients with high-grade glioblastoma
You may qualify if:
- Diagnosed with glioblastoma (World Health Organisation grade IV)
- Patient undergoing the standard Stupp treatment regimen
- Have had a pre-surgery scan and at least one follow-up scan post-chemoradiation
You may not qualify if:
- Insufficient clinical and radiological follow-up
- The patient's treatment deviates greatly from the standard Stupp regimen, such as they are recruited into interventional trials and sufficient information is not known about the patient's trial treatment
- Patients receiving treatment with Angiogenesis inhibitors such as bevacizumab prior to completion of the Stupp regimen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guy's and St Thomas' NHS Foundation Trustlead
- King's College Londoncollaborator
Study Sites (15)
Royal Sussex County Hospital, Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 5BE, United Kingdom
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, CF14 2TL, United Kingdom
Ninewells Hospital and Medical School, NHS Tayside
Dundee, DD1 9SY, United Kingdom
Hull Royal Infirmary, Hull University Teaching Hospitals NHS Trust
Hull, HU3 2KZ, United Kingdom
Leeds General Infirmary, The Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX, United Kingdom
Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
King's College Hospital, King's College Hospital NHS Trust
London, SE5 9RS, United Kingdom
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London, W6 8RF, United Kingdom
National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust
London, WC1N 3BG, United Kingdom
The Christie Hospital, The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust- Newcastle Freeman Hospital
Newcastle, NE7 7DN, United Kingdom
Nottingham University Hospitals NHS Trust- City Hospital
Nottingham, NG7 2UH, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, PR2 9HT, United Kingdom
The Royal Marsden Hospital, Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Booth
King's College London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 24, 2020
Study Start
March 21, 2019
Primary Completion
May 26, 2024
Study Completion
May 26, 2025
Last Updated
April 21, 2023
Record last verified: 2023-04