Trial ID: ISRCTN38834571
Other - Phase Unknown - No longer available
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-ultrasound-and-diffusion-tensor-imaging-during-surgery-for-glioblastoma-future-gb (added 17/03/2022) Background and study aims Glioblastoma (GB) is the most common primary brain tumour and is incurable. It grows very quickly from the brain tissue itself, rather than from a cancer elsewhere in the body. It is expected that the number of people with a brain tumour will rise by 6% in the UK between 2014 and 20351. However, prognosis (outcome) remains extremely poor, with most people surviving just over 12 months, and as a patients tumour grows patients experience a reduction (decline) in their quality of life. Therefore, we need to ensure quality of life, which remains difficult. The main treatments for GB are surgery, radiotherapy and chemotherapy, given in combination. For patients where it is thought that surgery will benefit, a surgeon often removes as much tumour as possible, whilst limiting the risk of causing damage, such as weakness, speech, or cognitive difficulties. However, which technology a surgeon should use during surgery to remove the tumour safely is unclear. This can affect how soon the cancer returns, what effects of surgery or symptoms a patient develops, and how a patient feels. High-frequency sound waves that create an image, called Ultrasound (US), is one of the tools a surgeon can use during the operation to find the tumour and see how much is removed. Another technology, Diffusion Tensor Imaging (DTI), allows important nerve pathways involved in certain functions, for example, speech/language, vision and movement, to be avoided in surgery. This trial aims to see if GB surgery with these extra technologies (tools) added to the standard ones, increases a patient’s good functioning quality of life, so-called Deterioration Free Survival (DFS). Who can participate? Adults aged 18 - 70 years, with a primary GB tumour which is maximally resectable and are suitable candidates for the treatment under investigation. What does the study involve? Participants will be randomly allocated to receive either brain surgery with standard methods without US and DTI, or surgery with the addition of US and DTI as well as standard tools. Patients may not know into which group they have been placed. They will be recruited from at least 15 NHS hospitals that routinely undertake GB surgery and have access to these tools. The trial will result in only minor changes to the present care pathway. After agreeing to take part, participants will be asked to complete questionnaires about their quality of life, such as their walking, ability to look after their personal hygiene, how they feel. They will also have a brief physical and cognitive/functional assessment before their surgery. Afterwards, the questionnaires and assessments will be repeated, before leaving hospital, and at three monthly intervals until 24 months after agreeing to take part (consenting). These will be combined with planned hospital visits. How long a patient lives will also be recorded. What are the possible benefits and risks of participating? There may not be any direct benefit to the patient, however, information gathered will benefit future patients. There are no additional risks. Where is the study run from? John Radcliffe Hospital (UK) When is the study starting and how long is it expected to run for? April 2020 to April 2027 Who is funding the study? National Institute for Health Research EME Programme (UK) Who is the main contact? Melody Chin, futuregb@nds.ox.ac.uk
University of Oxford
Source: https://www.isrctn.com/