Improving Treatment of Glioblastoma: Distinguishing Progression From Pseudoprogression

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04359745
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Guy's and St Thomas' NHS Foundation Trust
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Thomas Booth
Principal Investigator Affiliation King's College London
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

The impact of pseudoprogression is significant on patient care and medical research. The existing evidence shows that it is feasible to use Support Vector Machine and Deep Learning classification models for predicting survival using routine MRI images as well as differentiating progression from pseudoprogression. The investigators wish to capture signal changing over time in routine MRI images using parametric response maps (via a state-of-the-art postoperative-to preoperative image registration method that they have developed) and use such classifiers to differentiate progression from pseudoprogression. The research the investigators are proposing is needed in order to provide a solution to the problem of pseudoprogression and be implemented across the NHS easily and efficiently. Importantly, this does not depend on advanced imaging techniques. Data collected at KCH from the last 24 months shows that, even at a leading glioma imaging centre, only 66% of patients had advanced imaging (e.g. DSC-MRI) performed at the time of increase in contrast-enhancement i.e. possible progression. The primary aim of this research is to use routine clinical MRI data in order to train the classifier. This will increase the utility of the classifier, as such routine MRI data can be acquired by all imaging centres, and the new classifier can therefore provide a much more cost-efficient solution than an alternative classifier which may depend on advanced imaging techniques. Initial training, testing and cross validation of a classification model will be carried out using MRI data of glioblastoma obtained from publicly-accessible imaging archives and King's College Hospital (KCH), London. For clinical validation, the trained model will undergo testing using MRI data from patients recruited prospectively.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Brighton, United Kingdom

Status

Recruiting

Address

Royal Sussex County Hospital, Brighton and Sussex University Hospitals NHS Trust

Brighton, , BN2 5BE

Cardiff, United Kingdom

Status

Recruiting

Address

Velindre Cancer Centre, Velindre University NHS Trust

Cardiff, , CF14 2TL

Dundee, United Kingdom

Status

Recruiting

Address

Ninewells Hospital and Medical School, NHS Tayside

Dundee, , DD1 9SY

Hull, United Kingdom

Status

Recruiting

Address

Hull Royal Infirmary, Hull University Teaching Hospitals NHS Trust

Hull, , HU3 2KZ

Leeds, United Kingdom

Status

Recruiting

Address

Leeds General Infirmary, The Leeds Teaching Hospitals NHS Trust

Leeds, , LS1 3EX

London, United Kingdom

Status

Recruiting

Address

Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust

London, , SE1 9RT

London, United Kingdom

Status

Recruiting

Address

King's College Hospital, King's College Hospital NHS Trust

London, , SE5 9RS

London, United Kingdom

Status

Recruiting

Address

Charing Cross Hospital, Imperial College Healthcare NHS Trust

London, , W6 8RF

London, United Kingdom

Status

Recruiting

Address

National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust

London, , WC1N 3BG

Manchester, United Kingdom

Status

Recruiting

Address

The Christie Hospital, The Christie NHS Foundation Trust

Manchester, , M20 4BX

Newcastle, United Kingdom

Status

Recruiting

Address

Newcastle upon Tyne Hospitals NHS Foundation Trust- Newcastle Freeman Hospital

Newcastle, , NE7 7DN

Nottingham, United Kingdom

Status

Recruiting

Address

Nottingham University Hospitals NHS Trust- City Hospital

Nottingham, , NG7 2UH

University Hospitals Plymouth NHS Trust, Plymouth, United Kingdom

Status

Recruiting

Address

University Hospitals Plymouth NHS Trust

Plymouth, , PL6 8DH

Preston, United Kingdom

Status

Recruiting

Address

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, , PR2 9HT

Sutton, United Kingdom

Status

Recruiting

Address

The Royal Marsden Hospital, Royal Marsden NHS Foundation Trust

Sutton, , SM2 5PT

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