Ultrasound Imaging-based Measurement of Intra-osseous Vascular Response

NCT ID: NCT04396288

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2024-01-30

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.

Conditions

Blood Circulation Disorder; Bone Diseases, Metabolic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy volunteers

Group Type: EXPERIMENTAL

ultrasound imaging at the forearm and at the tibia

Intervention Type: DEVICE

ultrasound imaging will be performed at the radius bone (forearm) and at the tibia, before, during, and after a change of intraosseous blood flow

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 34499249 (View on PubMed)

Other Identifiers

C19-30

Identifier Type: -

Identifier Source: org_study_id