Trial ID: ISRCTN74928868
Other - Phase Unknown - Recruiting
Background and study aims Brain scans have made huge differences to the way brain tumours are diagnosed and treated. This study will build on this by using advanced MRI (Magnetic Resonance Imaging) to visualise the metabolism of brain tumours using a non-toxic specially modified form of glucose. Glucose is our most important source of energy. Glucose is made of carbon, hydrogen and oxygen atoms, and it can be modified to replace hydrogen atoms with non-toxic deuterium atoms (or “heavy” hydrogen atoms). This deuterium-labelled glucose has very similar biochemical characteristics to normal glucose but we can visualise its changing concentrations using MRI and also how it is broken down metabolically. This will help us understand how brain tumours metabolise glucose, which In the future, we hope that being able to visualise brain tumour metabolism will allow us to understand and visualise brain tumours in new ways. In the medium and long term, this could help reduce the need for surgical brain biopsies (samples), identify resistance to chemotherapy and reduce treatment-related side effects. However, to meet this goal we need to address fundamental questions about the feasibility of this approach. The main aim is - at this stage - to measure glucose metabolism in brain tumours after ingestion of modified deuterium-labelled glucose. Who can participate? Patients aged between 18 and 70 years referred to the East Midlands Neuro-Oncology/Haematology Service with a radiological diagnosis of a malignant brain tumour of a size that is measurable by the MRI scanner. Participants will be non-diabetic and are otherwise in good health with only minor symptoms or signs of their disease. What does the study involve? The intervention requires the participant to fast for 8-10 hours overnight. On the morning of the study, they will have their blood glucose measured with a simple finger-prick test. After this, they will drink 250 ml of flavoured non-toxic deuterium-labelled glucose. This contains the equivalent amount of added sugar as a large hot chocolate from a high street retailer. After 30 minutes, they will lie in the MRI scanner and measurements will be taken from the participant’s brain for no longer than 90 minutes. After the scan, participants will have another blood glucose finger-prick test and the participant will complete a questionnaire about their experience. Participants will be asked if they want to be recontacted and consider repeating the study after 3 months. The participant will then end the study and within 14 days of the end of the study, the participant's medical record will be reviewed to collect relevant information about their treatment and their brain tumour diagnosis. Participants will be asked if they want to be recontacted and consider repeating the study after 3 months. A small number of participants will be expected to repeat the study. What are the possible benefits and risks of participating? Beyond contributing to research intended to help other brain tumour patients in the long term, there are no expected direct benefits of participating in this study. Nevertheless, the opportunity to contribute to research and improve the lives of others can be a rewarding experience for many participants. There are no recognised risks associated with the deuterium-labelling of the glucose. Glucose is a food product and the amount used in the study is equivalent to the amount of added sugars found in foods available on the high street. As such, the interventions in this study can be considered very low risk. It is worth considering that the consumption of significant amounts of sugar can cause very high blood glucose levels (or paradoxically, low blood glucose levels). The risk of this will be reduced by excluding people with blood glucose disorders (e.g. diabetes mellitus), and measuring glucose levels after the scan has been completed. The study will also involve taking part in research at an extraordinary time in the participant's life, where there will likely be significant anxiety surrounding diagnosis. Some people may find involvement in brain tumour research burdensome and upsetting. The psychological impact of participation will be mitigated by consulting care providers regarding patient suitability. Recruitment will also be conducted by a clinically trained member of the study team with experience in managing brain tumour patients. The experience of an MRI can be claustrophobic and unpleasant and involves exposure to loud noises. Participants will have been already accustomed to MRI as part of their brain tumour treatment. Patients with claustrophobia will be excluded from the study and patients will be supplied with ear defenders. Patients will also have access to a microphone to communicate with the radiographer. Indeed, the team at Sir Peter Mansfield Imaging Centre (SPMIC) are exceptionally experienced with conducting imaging studies in a sensitive and caring manner. Where is the study run from? The Sir Peter Mansfield Imaging Centre (SPMIC), University Park, which is the main campus of University of Nottingham (UK) When is the study starting and how long is it expected to run for? February 2023 to September 2028 Who is funding the study? The University of Nottingham (UK) Who is the main contact? Mr Milo Hollingworth, milo.hollingworth@nottingham.ac.uk
University of Nottingham
Source: https://www.isrctn.com/