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Development of an Improved Method of Measuring Total Body Bone Perfusion Using Total-body PET/CT

2026年10月1日 更新者:King's College London

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

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

观察性的

注册 (估计的)

10

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • London、英国、SE1 9RT
        • 招聘中
        • King's College London
        • 接触:
        • 首席研究员:
          • Prof. Gary Cook

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月23日

初级完成 (估计的)

2027年10月31日

研究完成 (估计的)

2027年10月31日

研究注册日期

首次提交

2026年9月25日

首先提交符合 QC 标准的

2026年10月1日

首次发布 (实际的)

2026年10月6日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年9月1日

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)?

不

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

不

研究美国 FDA 监管的设备产品

不

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