Healthy Volunteers - Male and FemaleNCT07860346
Development of an Improved Method of Measuring Total Body Bone Perfusion Using Total-body PET/CT
An observational study of Healthy Volunteers - Male and Female, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers - Male and Female
- What is being tested?
- 1-hour Total Body PET/CT scan using the tracer [18F]-sodium fluoride
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2026to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ten healthy volunteers aged over 50 years old
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE1 9RT
Amelia Moore, PhD, amelia.moore@kcl.ac.uk
Prof. Gary Cook
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers - Male and Female
- Being tested
- 1-hour Total Body PET/CT scan using the tracer [18F]-sodium fluoride
- Keywords
- total-body PET/CT, bone perfusion, [18F]-sodium fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-hour Total Body PET/CT scan using the tracer [18F]-sodium fluorideDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers aged over 50 years | Will undergo 1-hour PET/CT scan Receives: Diagnostic Test: 1-hour Total Body PET/CT scan using the tracer [18F]-sodium fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 1 month
Secondary outcomes (1)
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.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start23 Sep 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers - Male and FemaleStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860346
- Sponsor's protocol ID
- 368515
- Other IDs
- OPP1122
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study only in healthy volunteers
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Improved Method of Measuring Total Body Bone Perfusion Using Total-body PET/CT
- ClinicalTrials.gov ID
- NCT07860346
- Acronym / sponsor ID
- 368515
- Conditions
- Healthy Volunteers - Male and Female
- Keywords
- total-body PET/CT, bone perfusion, [18F]-sodium fluoride
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers aged over 50 years | – | Diagnostic Test: 1-hour Total Body PET/CT scan using the tracer [18F]-sodium fluorideWill undergo 1-hour PET/CT scan |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ten healthy volunteers aged over 50 years old
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-hour Total Body PET/CT scan using the tracer [18F]-sodium fluorideEach 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). | Diagnostic test | Healthy volunteers aged over 50 years |
Primary outcome
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.
Time frame: 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 secondary outcome
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.
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. This is a pilot study only in healthy volunteers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers - Male and Female, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelia Moore, PhD (+44 0207 188 4092, amelia.moore@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.