Non-invasive In-vivo Characterisation of Alzheimer's Disease Using Fast-field Cycling Magnetic Resonance Imaging (FFC MRI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
Fast Field-Cycling MRI (FFC MRI) is a new scanning technology being developed at the University of Aberdeen. Previous pilot studies by the team on osteoarthritis, breast cancer, musculoskeletal cancer, liver fibrosis, thrombosis and muscle damage have demonstrated that FFC MRI provides useful information for clinical diagnostics in a variety of pathologies.
The aim of this study is to ascertain if brain imaging with FFC MRI yields any useful information in the diagnosis and evaluation of Alzheimer's disease.
详细描述
Alzheimer's disease (AD) patients and appropriate controls will be identified by consultants working with the patient group.
Potential participants will be approached by letter by their clinician. The purpose of this study will be explained to them and they will be asked for signed informed consent.
Communication between the clinical team and FFC-MRI research team will ensure that any appointment for FFC-MRI is made at a time that is convenient for the patient and clinical team.
The aim is to recruit 25 individuals with AD and 25 age matched controls.
FFC-MRI images will be acquired on dedicated equipment specifically built for the purpose of imaging human volunteers and patients. Where clinically appropriate patents will undergo other imaging procedures as part of their normal NHS care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with probable Alzheimer's disease, based upon cognitive testing (MMSE) and SPECT imaging.
- •Controls will be participants without known cognitive impairment or Alzheimer's disease.
- •Subjects capable of giving informed consent.
- •Age 21 and above
排除标准
- •MRI-incompatible condition detected in the MR screening sheet such as some metallic implanted devices (see MR screening sheet in the project files).
- •Claustrophobia
- •Waist circumference larger than 102 cm, due to the limited bore size of the scanner.
- •Restrictions to mobility such that patients are unable to be positioned in scanner by trained research radiographer e.g. severe kyphosis
- •Cognitive impairment of sufficient severity that the participant does not have capacity to give informed consent
- •Pregnancy
- •Persons who might not adequately understand verbal explanations or written information given in English, or who have special communication needs
- •Dementia of sufficient severity that the participant cannot give informed consent
研究组 & 干预措施
Alzheimer's patients
Patient diagnosed with early onset Alzheimer's disease.
干预措施: FFC-MRI scan (Device)
Control
Healthy volunteers that do not have Alzheimer's disease.
干预措施: FFC-MRI scan (Device)
结局指标
主要结局
Primary Outcome
时间窗: 12 weeks
The FFC-MRI T1 maps of patients and controls, with SPECT findings for validation. The outcome used for the primary research question will be the statistical significance in the difference of image contrast between the control group and the patient group. The presence of AD in the patient group will be estimated using the current clinical standard, cognitive testing with MoCA) or MMSE and blood flow SPECT CT imaging. If the participant has recently had an MRI scan using 3T MRI, we will ask for permission from the participant to access these images and use them for comparison. The level of significance of the differences will be derived using the statistical test most adapted to the contrast, depending on the distribution profile across the samples. No previous data exist to guide our choice.
次要结局
- Secondary Outcome(12 weeks)