Metabolic imaging of brain tumours using deuterium-labelled glucose
- Conditions
- Malignant brain tumoursCancer
- Registration Number
- ISRCTN74928868
- Lead Sponsor
- niversity of Nottingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 45
1. Radiological or tissue diagnosis of a malignant brain tumour
2. Aged 18-70 years
3. A tumour size detectable by the imaging sequence
4. Able to fully comprehend the informed consent process and give informed consent
5. Able to walk independently or with only minor support to the scanner (i.e. 10 metres without rest)
6. Able to carry on normal activity and to work with no special care needed. Normal activity some effort may be required and there may be some signs or symptoms of disease (Performance status >80)
7. Completed clinic or telephone screening
8. American Society of Anaesthesiologists (ASA) Physical Status Classification I or II; normal or healthy or with only mild systemic disease or mild diseases only without substantive functional limitations
1. Likely to experience distress from participating in the study as assessed by the care provider
2. ASA Physical Classification Status III to IV; Severe systemic disease - moribund
3. A person who has received a diagnosis of Diabetes Mellitus defined as an 8 h fasting blood glucose =7.0 mmol/L (126 mg/dL), 2 h post 75 g oral glucose tolerance test (OGTT) =11.1 mmol/L (200 mg/dL), HbA1c =6.5% or in patients with symptoms of hyperglycaemic, a random plasma glucose of =11.1 mmol/L (200 mg/dL)
4. A person who has received a diagnosis of steroid-induced diabetes mellitus as an abnormal increase in blood glucose associated with the use of glucocorticoids in a patient with or without a prior history of diabetes mellitus.
5. A person who has received a diagnosis of pre-diabetes defined as a HbA1c of 5.7-6.4% or an second serum glucose measurement between 7.8- 11 mmol/L after an oral glucose tolerance test
6. Non-fluent English that would prohibit safe communication between the participant and radiographer via a microphone inside the scanner
7. Seizures within the last month despite anti-epileptic treatment
8. Inability to complete the MRI-Safety Questionnaire
9. Implantable medical cardiac, neurological devices (i.e. pacemaker, ICD, neurostimulator, aneurysm clip)
10. Having taken part in a research study in the last 3 months involving invasive procedures, ionising radiation or an inconvenience allowance. This excludes repeat particpants of the GLYCODMI Brain Tumour Study or the Tessa Jowell BRAIN MATRIX Study (NCT04274283), which is an observational platform study that biobanks tumour samples and blood for molecular analysis.
11. Having enrolment in GLYCODMI Brain Tumour Study and already completed two scans under study conditions
12. A symptom or condition that impedes lying flat for prolonged periods (90 minutes) (e.g. heart failure)
13. Cannot dress and undress independently
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Deuterium-labeled glucose and downstream metabolites and signal-to-noise ratio measured using magnetic resonance imaging/spectroscopy in the brain tumours compared to disease-free brain at a single timepoint
- Secondary Outcome Measures
Name Time Method <br> 1. Deuterium-labelled glucose and downstream metabolites within different types of brain tumour (malignant glioma, brain metastasis and cerebral lymphoma) measured using magnetic resonance imaging/spectroscopy at a single timepoint<br> 2. Deuterium-labelled glucose and downstream metabolites in brain tumours measured using magnetic resonance imaging/spectroscopy over time (3-6 months)<br> 3. Tolerability of deuterium metabolic imaging measured using the MRI-Anxiety Questionnaire at a single timepoint<br>