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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Amelia Moore, PhD
- Número de telefone: +44 0207 188 4092
- E-mail: amelia.moore@kcl.ac.uk
Locais de estudo
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London, Reino Unido, SE1 9RT
- Recrutamento
- King's College London
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Contato:
- Amelia Moore, PhD
- E-mail: amelia.moore@kcl.ac.uk
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Investigador principal:
- Prof. Gary Cook
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Ten healthy volunteers aged over 50 years old
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: OTHER
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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.
Prazo: 1 month
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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.
Prazo: 1 month
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
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Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 368515
- OPP1122 (Número de outro subsídio/financiamento: National PET imaging platform research pilot funding (MRC))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
This is a pilot study only in healthy volunteers
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