Ultrasound Imaging-based Measurement of Intra-osseous Vascular Response

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.

Study Overview

• Status: Completed
• Conditions: Bone Diseases, Metabolic; Blood Circulation Disorder
• Intervention / Treatment: Device: ultrasound imaging at the forearm and at the tibia

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Service de Radiologie polyvalente et oncologique, hôpital La Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers	Device: ultrasound imaging at the forearm and at the tibia; ultrasound imaging will be performed at the radius bone (forearm) and at the tibia, before, during, and after a change of intraosseous blood flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During sitting position (up to 5 minutes), then during supine head-down tilt position (up to 5 minutes)

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): December 14, 2022
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Metabolic Diseases
• Other Study ID Numbers: C19-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No