Development of an Improved Method of Measuring Total Body Bone Perfusion Using Total-body PET/CT
Broken bones (fractures) are a common problem in several serious health conditions, such as osteoporosis, kidney failure, and sickle cell disease. To better understand and treat these diseases, researchers need a reliable way to measure how much blood flows through our bones.
In animal studies, a special scan called PET (Positron Emission Tomography) has been used successfully to measure bone blood flow. This scan uses a safe, low dose of a radioactive substance called sodium fluoride, which helps show how blood moves through the bones. However, using this method in people has been difficult in the past because older PET scanners were not sensitive enough to give accurate results.
Recently, St Thomas' Hospital in London has received two new, state-of-the-art PET scanners. These scanners can take pictures of the whole body at once and are much more sensitive than older models. They can also take images of the heart during the scan, which is important because it allows researchers to measure how much of the radioactive tracer is being delivered to the bones through the bloodstream. This is a big improvement over older, more invasive methods that required taking many blood samples.
The main goal of this pilot study is to develop a better, more reliable way to measure bone blood flow in healthy volunteers using these new PET scanners. The researchers also want to check if measuring the tracer in the heart is as good as, or better than, the previous method of taking frequent blood samples.
To do this, the researchers will invite ten healthy volunteers-men and postmenopausal women over the age of 50-to take part in our study. Each volunteer will have a one-hour PET/CT scan, which takes images from the head down to the upper thighs after a small injection of the radioactive tracer. To compare the new method with the old one, the researchers will also take five small blood samples from the volunteer's arm at different times during the scan.
The research team hope that this study will lead to better ways of studying and treating bone diseases in the future, making the process easier and less invasive for patients.
研究概览
地位
详细说明
This is a prospective single centre non-randomised exploratory pilot study. Ten healthy volunteers aged over 50 years will be recruited via the King's College London (KCL) research recruitment page and circular email sent to KCL staff. Each healthy volunteer will have a 1-hour dynamic TB-PET/CT scan from vertex to mid-thighs following a bolus injection of 90 MBq of [18F]-sodium fluoride ([18F]-NaF) to measure bone perfusion (K1) and regional bone plasma clearance (Ki). Five venous blood samples will be collected at 5, 15, 30, 45, and 60 minutes after injection. These will be used to verify the left ventricle (LV) measurements of the arterial input function (AIF) from the image of the heart, and correct the whole blood measurements in the LV to measurements of plasma concentration.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Amelia Moore, PhD
- 电话号码:+44 0207 188 4092
- 邮箱:amelia.moore@kcl.ac.uk
学习地点
-
-
-
London、英国、SE1 9RT
- 招聘中
- King's College London
-
接触:
- Amelia Moore, PhD
- 邮箱:amelia.moore@kcl.ac.uk
-
首席研究员:
- Prof. Gary Cook
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Ten healthy volunteers aged over 50 years old
描述
Inclusion Criteria:
- 5 male and 5 female healthy volunteers aged over 50 years
- No metabolic bone disease (e.g. osteoporosis)
- No metastatic bone disease
- Good venous access
- Must be able to lie flat and remain motionless for the duration of the scan (60 minutes)
- Good bladder control
Exclusion Criteria:
- Over 1.85 metres (6.1 feet) in height to ensure adequate skeletal coverage
- Over 95 kg (15 stone) in weight to ensure image quality
- Claustrophobia
- Uncontrolled high blood pressure
- Presence of any metal in the body or heart pacemaker
- Pregnant women
- Not currently or previously been involved within the last 12 months on trials investigating other imaging methods involving ionising radiation
学习计划
研究是如何设计的?
设计细节
- 观测模型:OTHER
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Healthy volunteers aged over 50 years
Will undergo 1-hour PET/CT scan |
Each volunteer will have a 1-hour dynamic TB-PET/CT scan from vertex to mid-thighs following a bolus injection of 90 MBq of [18F]-sodium fluoride ([18F]-NaF) to measure bone perfusion (K1) and regional bone plasma clearance (Ki). |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To measure bone perfusion (K1) and bone plasma clearance (Ki) with [18F]-sodium fluoride TB-PET/CT at multiple sites across the whole skeleton in 10 healthy volunteers, both are measured in units of mL per min per mL.
大体时间:1 month
|
Dynamic [18F]-sodium fluoride PET/CT scans can measure both effective bone plasma flow (K1), and bone plasma clearance (Ki), the latter reflecting regional bone formation. Both are measured in units of mL per min per mL (or mL min-¹ mL-¹), which signifies the volume of plasma cleared of the tracer per minute per unit volume of tissue. |
1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To develop an improved method of measuring the arterial input function (AIF) by using a volume of interest (VOI) in the left ventricle (LV) of the heart in the same 10 healthy volunteers.
大体时间:1 month
|
This is an important secondary outcome because both K1 and Ki require knowing the arterial input function (AIF), which is essentially how much tracer is available to the bone. Previously, the only accurate way of measuring this was by direct arterial blood sampling, which is an invasive procedure, and an alternative technique was to derive a semi-population input function. However, the new scanners include the heart in the field of view enabling the AIF to be measured more reliably, and the researchers hope that this will significantly improve the measurement of bone blood flow and bone formation in the future. |
1 month
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 368515
- OPP1122 (其他赠款/资助编号:National PET imaging platform research pilot funding (MRC))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
This is a pilot study only in healthy volunteers
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.