Blood Circulation DisorderNCT04396288
Ultrasound Imaging-based Measurement of Intra-osseous Vascular Response
A study testing ultrasound imaging at the forearm and at the tibia in people with Blood Circulation Disorder and Bone Diseases, Metabolic, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Blood circulation within bone is thought to have a key role in bone growth, in fracture healing and in the development of bone diseases like osteoporosis. Current medical imaging techniques such as conventional ultrasonography fail to detect blood circulation within bone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Circulation Disorder, Bone Diseases, Metabolic
- What is being tested?
- ultrasound imaging at the forearm and at the tibia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2021to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be 18 years old or older
- speaks good French
- have an affiliation to a French Healthcare system (health insurance)
- sign the informed consent
Who cannot join
- bone fracture at the tibia or at the forearm less than one year ago
- injury or wound still present at the tibia or at the forearm
- pregnant women
- protected persons
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Radiologie polyvalente et oncologique, hôpital La Pitié-Salpêtrière
Paris
About this study
Official title: Characterization of Intra-osseous Vascular Response With Ultrasound Imaging on Healthy Volunteers
Blood circulation within bone is thought to have a key role in bone growth, in fracture healing and in the development of bone diseases like osteoporosis. Current medical imaging techniques such as conventional ultrasonography fail to detect blood circulation within bone. The investigators propose to develop a new type of ultrasonography called intraosseous functional ultrasonography that will enable the detection and the characterization of blood circulation in solid bone tissue, marrow and soft tissues surrounding bone (muscle for instance). Because most soft tissues are essentially made of water, the speed of sound in soft tissues is close to that in water and it varies only a little between different types of soft tissues. For this reason, clinical ultrasound scanners used for ultrasonography assume that the speed of sound in the human body is the same for all types of soft tissues. This assumption is reasonable in soft tissues, but it does not hold in bone because solid bone tissue is much stiffer than soft tissues. Seismologists have extensive experience in producing images of the structure of the Earth based on the analysis of elastic waves which follow the same laws of Physics as ultrasound waves. The subsurface of the Earth contains layers of solid materials and liquids, consequently it is very similar to a region of the human body containing bone and soft tissues. Therefore the investigators will first work on the adaption of time-tested seismic imaging methods to make ultrasonography of bone possible. Once a correct image of bone is obtained, the investigators will use an ultrasound scanner dedicated to research to repeat this image hundreds of times per second, very much like a slow motion video. Because blood is moving while bone is still, the intensity in the image is being slightly changed where blood is moving. Thus the analysis of these changes makes it possible to detect and characterize blood flow within bone. In this way the investigators expect to be able to detect blood flowing with a speed as low as a few millimeters per second. Finally the sensitivity of the technique to detect and characterize blood circulation in bone will be evaluated in patients at the hospital and in healthy volunteers. The success of this work will help gaining knowledge on the role of blood circulation within bone. In the long term, it may help in the diagnosis of bone diseases.
- Being tested
- ultrasound imaging at the forearm and at the tibia
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound imaging at the forearm and at the tibiaDevice
ultrasound imaging will be performed at the radius bone (forearm) and at the tibia, before, during, and after a change of intraosseous blood flow
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Not described Receives: Device: ultrasound imaging at the forearm and at the tibia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of velocity of blood flow in cortical bone and in marrow, before, during, and after the action of an automatic blood pressure cuff at the forearm (radius bone)
Using ultrasound imaging, the velocity (mm/s) of blood circulation in cortical bone and in marrow will be assessed at the forearm (radius bone). Changes induced by the action of an automatic blood pressure cuff will be measured.
Measured: Up to 10 secondes immediately before the action of an automatic blood pressure cuff, during the action of an automatic blood pressure cuff (about 20 secondes), and up to 10 secondes immediately after the action of an automatic blood pressure cuff
Change of direction of blood flow in cortical bone and in marrow, before, during, and after the action of an automatic blood pressure cuff at the forearm (radius bone)
Using ultrasound imaging, the direction (degree) of blood circulation in cortical bone and in marrow will be assessed at the forearm (radius bone). Changes induced by the action of an automatic blood pressure cuff will be measured.
Measured: Up to 10 secondes immediately before the action of an automatic blood pressure cuff, during the action of an automatic blood pressure cuff (about 20 secondes), and up to 10 secondes immediately after the action of an automatic blood pressure cuff
Change of velocity of blood flow in cortical bone and in marrow at the tibia, if changing position from sitting position to supine head-down tilt position
Using ultrasound imaging, the velocity (mm/s) of blood circulation in cortical bone and in marrow will be assessed at the tibia. Changes induced by the change of position will be measured.
Measured: During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)
Change of direction of blood flow in cortical bone and in marrow at the tibia, if changing position from sitting position to supine head-down tilt position
Using ultrasound imaging, the direction (degree) of blood circulation in cortical bone and in marrow will be assessed at the tibia. Changes induced by the change of position will be measured.
Measured: During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)
Secondary outcomes (2)
Repeatability of the measurement of the change of intraosseous blood circulation at the forearm under the action of an automatic blood pressure cuff
The action of the automatic blood pressure cuff will be repeated 5 times. The ultrasound transducer will be systematically removed and replaced between each repetition, in order to assess the reproducibility of the measurement.
Measured: Up to 10 secondes immediately before the action of an automatic blood pressure cuff, during the action of an automatic blood pressure cuff (about 20 secondes), and up to 10 secondes immediately after the action of an automatic blood pressure cuff
Repeatability of the measurement of the change of intraosseous blood circulation at the tibia when changing position from sitting position to supine head-down tilt position
The change of position from sitting position to supine head-down tilt position will be repeated 5 times. The ultrasound transducer will be systematically removed and replaced between each repetition, in order to assess the reproducibility of the measurement.
Measured: During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start14 Sep 2021
- Primary completion14 Dec 2022
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Circulation DisorderStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396288
- Sponsor's protocol ID
- C19-30
- Status last verified
- Mar 2024
- First submitted
- 5 May 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cloutier G, Destrempes F, Yu F, Tang A. Quantitative ultrasound imaging of soft biological tissues: a primer for radiologists and medical physicists. Insights Imaging. 2021 Sep 9;12(1):127. doi: 10.1186/s13244-021-01071-w.
PubMed 34499249
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Intra-osseous Vascular Response With Ultrasound Imaging on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04396288
- Acronym / sponsor ID
- C19-30
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 20 May 2020 (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.
Blood circulation within bone is thought to have a key role in bone growth, in fracture healing and in the development of bone diseases like osteoporosis. Current medical imaging techniques such as conventional ultrasonography fail to detect blood circulation within bone. The investigators propose to develop a new type of ultrasonography called intraosseous functional ultrasonography that will enable the detection and the characterization of blood circulation in solid bone tissue, marrow and soft tissues surrounding bone (muscle for instance). Because most soft tissues are essentially made of water, the speed of sound in soft tissues is close to that in water and it varies only a little between different types of soft tissues. For this reason, clinical ultrasound scanners used for ultrasonography assume that the speed of sound in the human body is the same for all types of soft tissues. This assumption is reasonable in soft tissues, but it does not hold in bone because solid bone tissue is much stiffer than soft tissues. Seismologists have extensive experience in producing images of the structure of the Earth based on the analysis of elastic waves which follow the same laws of Physics as ultrasound waves. The subsurface of the Earth contains layers of solid materials and liquids, consequently it is very similar to a region of the human body containing bone and soft tissues. Therefore the investigators will first work on the adaption of time-tested seismic imaging methods to make ultrasonography of bone possible. Once a correct image of bone is obtained, the investigators will use an ultrasound scanner dedicated to research to repeat this image hundreds of times per second, very much like a slow motion video. Because blood is moving while bone is still, the intensity in the image is being slightly changed where blood is moving. Thus the analysis of these changes makes it possible to detect and characterize blood flow within bone. In this way the investigators expect to be able to detect blood flowing with a speed as low as a few millimeters per second. Finally the sensitivity of the technique to detect and characterize blood circulation in bone will be evaluated in patients at the hospital and in healthy volunteers. The success of this work will help gaining knowledge on the role of blood circulation within bone. In the long term, it may help in the diagnosis of bone diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Device: ultrasound imaging at the forearm and at the tibia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be 18 years old or older
- speaks good French
- have an affiliation to a French Healthcare system (health insurance)
- sign the informed consent
Key exclusion criteria (4 listed)
- bone fracture at the tibia or at the forearm less than one year ago
- injury or wound still present at the tibia or at the forearm
- pregnant women
- protected persons
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 |
|---|---|---|
| ultrasound imaging at the forearm and at the tibiaultrasound imaging will be performed at the radius bone (forearm) and at the tibia, before, during, and after a change of intraosseous blood flow | Device | Healthy volunteers |
Primary outcome
Change of velocity of blood flow in cortical bone and in marrow, before, during, and after the action of an automatic blood pressure cuff at the forearm (radius bone)
Time frame: Up to 10 secondes immediately before the action of an automatic blood pressure cuff, during the action of an automatic blood pressure cuff (about 20 secondes), and up to 10 secondes immediately after the action of an automatic blood pressure cuff
Using ultrasound imaging, the velocity (mm/s) of blood circulation in cortical bone and in marrow will be assessed at the forearm (radius bone). Changes induced by the action of an automatic blood pressure cuff will be measured.
Change of direction of blood flow in cortical bone and in marrow, before, during, and after the action of an automatic blood pressure cuff at the forearm (radius bone)
Time frame: Up to 10 secondes immediately before the action of an automatic blood pressure cuff, during the action of an automatic blood pressure cuff (about 20 secondes), and up to 10 secondes immediately after the action of an automatic blood pressure cuff
Using ultrasound imaging, the direction (degree) of blood circulation in cortical bone and in marrow will be assessed at the forearm (radius bone). Changes induced by the action of an automatic blood pressure cuff will be measured.
Change of velocity of blood flow in cortical bone and in marrow at the tibia, if changing position from sitting position to supine head-down tilt position
Time frame: During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)
Using ultrasound imaging, the velocity (mm/s) of blood circulation in cortical bone and in marrow will be assessed at the tibia. Changes induced by the change of position will be measured.
Change of direction of blood flow in cortical bone and in marrow at the tibia, if changing position from sitting position to supine head-down tilt position
Time frame: During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)
Using ultrasound imaging, the direction (degree) of blood circulation in cortical bone and in marrow will be assessed at the tibia. Changes induced by the change of position will be measured.
2 secondary outcomes
Repeatability of the measurement of the change of intraosseous blood circulation at the forearm under the action of an automatic blood pressure cuff
Time frame: Up to 10 secondes immediately before the action of an automatic blood pressure cuff, during the action of an automatic blood pressure cuff (about 20 secondes), and up to 10 secondes immediately after the action of an automatic blood pressure cuff
Repeatability of the measurement of the change of intraosseous blood circulation at the tibia when changing position from sitting position to supine head-down tilt position
Time frame: During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 34499249Cloutier G, Destrempes F, Yu F, Tang A. Quantitative ultrasound imaging of soft biological tissues: a primer for radiologists and medical physicists. Insights Imaging. 2021 Sep 9;12(1):127. doi: 10.1186/s13244-021-01071-w.
- Individual participant dataSharing planned: Undecided
Related trials for Blood Circulation Disorder
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis
Not yet recruitingObservational study
Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension
Idiopathic Intracranial Hypertension
Not yet recruitingObservational study
Heart and Brain Blood Flow in Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA)
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Not yet recruitingEarly Phase 1
Human Cerebrovascular Blood Flow and Sex Differences in Metabolic Syndrome
Metabolic Syndrome
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound imaging at the forearm and at the tibia in people with Blood Circulation Disorder and Bone Diseases, Metabolic, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Sep 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of velocity of blood flow in cortical bone and in marrow, before, during, and after the action of an automatic blood pressure cuff at the forearm (radius bone) (time frame: Up to 10 secondes immediately before the action of an automatic blood pressure cuff, during the action of an automatic blood pressure cuff (about 20 secondes), and up to 10 secondes immediately after the action of an automatic blood pressure cuff). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04396288, which also lists 1 linked publication.
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 4 Sep 2025.