ISRCTN74928868进行中（未招募）Unknown
Optimising deuterium magnetic resonance for in vivo assessment of cerebral glycolytic flux in brain tumours
niversity of Nottingham0 个研究点目标入组 45 人开始时间: 2023年7月5日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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