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Recruiting NCT07860346

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

Conditions: Healthy Volunteers - Male and Female

Sex: All
Ages: 50 Years – N/A
Healthy volunteers: Yes
Enrollment: 10
Sponsor: King's College London

Location: King's College London London

Summary

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07860346). StuddyBuddy aggregates publicly available trial information.