Ultrasound Imaging-based Measurement of Intra-osseous Vascular Response
Primary Purpose
Blood Circulation Disorder, Bone Diseases, Metabolic
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ultrasound imaging at the forearm and at the tibia
Sponsored by
About this trial
This is an interventional basic science trial for Blood Circulation Disorder
Eligibility Criteria
Inclusion Criteria:
- be 18 years old or older
- speaks good French
- have an affiliation to a French Healthcare system (health insurance)
- sign the informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Service de Radiologie polyvalente et oncologique, hôpital La Pitié-Salpêtrière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04396288
First Posted
May 5, 2020
Last Updated
October 9, 2023
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT04396288
Brief Title
Ultrasound Imaging-based Measurement of Intra-osseous Vascular Response
Official Title
Characterization of Intra-osseous Vascular Response With Ultrasound Imaging on Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
September 14, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Circulation Disorder, Bone Diseases, Metabolic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ultrasound imaging at the forearm and at the tibia
Intervention Description
ultrasound imaging will be performed at the radius bone (forearm) and at the tibia, before, during, and after a change of intraosseous blood flow
Primary Outcome Measure Information:
Title
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)
Description
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.
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
Title
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)
Description
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.
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
Title
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
Description
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.
Time Frame
During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)
Title
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
Description
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.
Time Frame
During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)
Secondary Outcome Measure Information:
Title
Repeatability of the measurement of the change of intraosseous blood circulation at the forearm under the action of an automatic blood pressure cuff
Description
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.
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
Title
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
Description
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.
Time Frame
During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
be 18 years old or older
speaks good French
have an affiliation to a French Healthcare system (health insurance)
sign the informed consent
Exclusion Criteria:
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
Facility Information:
Facility Name
Service de Radiologie polyvalente et oncologique, hôpital La Pitié-Salpêtrière
City
Paris
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ultrasound Imaging-based Measurement of Intra-osseous Vascular Response
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