Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06142747
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2023-11-15
Brief Title:
Tracking of Red Blood Cells Using Super Resolution Ultrasound in Persons With Healthy or Overuse Injured Tendons
Sponsor:
University Hospital Bispebjerg and Frederiksberg
Organization:
University Hospital Bispebjerg and Frederiksberg
Study Overview
Official Title:
SUper-Resolution Ultrasound Imaging of Erythrocytes SURE in Normal and Tendinopathic Tendons
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SURE-TEND
Brief Summary:
The goal of this observational study is to test whether a new ultrasound method called SUper Resolution ultrasound imaging of Erythrocytes SURE can image the small blood vessels found in tendons of persons with a tendon overuse injury tendinopathy The main questions it aims to answer are
Is the method sensitive enough to detect the smallest blood vessels
What information about the blood flow can be obtained flow velocity pressure shape of the vessels
Can the flow in an injured tendon be distinguished from that of a healthy one
Participants will receive a non-invasive ultrasound examination of their Achilles heel or patellar knee tendon using an advanced high frequency research ultrasound system
Researchers will compare participants with either an Achilles or patellar tendon overuse injury to participants with healthy tendons to see if there are distinct differences in the blood vessels that could help diagnose and treat the injuries
Is the method sensitive enough to detect the smallest blood vessels
What information about the blood flow can be obtained flow velocity pressure shape of the vessels
Can the flow in an injured tendon be distinguished from that of a healthy one
Participants will receive a non-invasive ultrasound examination of their Achilles heel or patellar knee tendon using an advanced high frequency research ultrasound system
Researchers will compare participants with either an Achilles or patellar tendon overuse injury to participants with healthy tendons to see if there are distinct differences in the blood vessels that could help diagnose and treat the injuries
Detailed Description:
Studies have reported an enlargement of the microvascular network in human tendons with a chronic overuse injury tendinopathy Ingrowth of new vessels and accompanying nerves have been proposed to be the cause of painful symptoms in patients with tendinopathy Doppler ultrasound is the most common imaging modality to clinically investigate tendon neovascularization This measurement is clinically useful but its sensitivity is limited which means that no Doppler flow is visible in healthy tendons despite invasive techniques having shown the presence of such flow The lack of sensitivity in Doppler ultrasound means that it is impossible to accurately follow the progression from the healthy state with zero Doppler to a chronic state with detectable Doppler as well as the reverse process during healing of the injury
The present study is designed to evaluate an ultrasound method called Super-resolution ultrasound imaging of erythrocytes SURE which is a new imaging technique for visualization and quantification of the microvasculature of tissues The method is built on a technique called super-resolution ultrasound imaging SRI where an ultrasound contrast agent is injected into the bloodstream and tracked inside the vessels to build an image of the microvasculature With SURE no contrast agent is needed it relies only on standard ultrasound to track the erythrocytes and thereby avoid invasive procedures
The aim of this study is to determine the applicability of the SURE technique to detecting microvascular flow changes with tendinopathy by quantifying flow parameters in SURE images of healthy and tendinopathic tissues
The study is designed as a cross-sectional single-center diagnostic case-control trial on participants who are either healthy or have had a tendinopathy in their Achilles or patellar tendon A formal sample size estimate cannot be made since the SURE method has not been clinically applied before the sample sizes are therefore based on our experience with other outcomes for this patient group
The study-specific medical device consists of 2 main components a scanner system and an ultrasound probe
The ultrasound scanner Vantage 256 scanner Verasonics Kirkland Washington USA
The probe GE L8-18i-D transducer GE Healthcare Chicago Illinois USA
Both components are marked for conformity within the European Union CE The entire system including the probe and scanner system would classify as a Class IIa medical device but it has not gone through a notified body as the system is not intended for commercial use
For measurements the participant is placed on a bed and scanned with conventional ultrasound to locate the region of tendon injury or the thickest part of the tendon for healthy participants and characterize it with grey-scale and Doppler imaging The region of interest is marked on the skin and the ultrasound probe is affixed to the tendon at the specified location using a custom holder to minimize motion The probe is then be disconnected from the conventional ultrasound scanner and connected to the Vantage 256 scanner to record SURE images Image data may be collected for up to 1 minute Two scans at the same location are used for estimating repeatability The imaging setup and image processing will be adjusted to maximize quality of the SURE images From the images the vessel density and potentially other parameters flow rate flow orientation vessel dimensions etc may be determined
The present study is designed to evaluate an ultrasound method called Super-resolution ultrasound imaging of erythrocytes SURE which is a new imaging technique for visualization and quantification of the microvasculature of tissues The method is built on a technique called super-resolution ultrasound imaging SRI where an ultrasound contrast agent is injected into the bloodstream and tracked inside the vessels to build an image of the microvasculature With SURE no contrast agent is needed it relies only on standard ultrasound to track the erythrocytes and thereby avoid invasive procedures
The aim of this study is to determine the applicability of the SURE technique to detecting microvascular flow changes with tendinopathy by quantifying flow parameters in SURE images of healthy and tendinopathic tissues
The study is designed as a cross-sectional single-center diagnostic case-control trial on participants who are either healthy or have had a tendinopathy in their Achilles or patellar tendon A formal sample size estimate cannot be made since the SURE method has not been clinically applied before the sample sizes are therefore based on our experience with other outcomes for this patient group
The study-specific medical device consists of 2 main components a scanner system and an ultrasound probe
The ultrasound scanner Vantage 256 scanner Verasonics Kirkland Washington USA
The probe GE L8-18i-D transducer GE Healthcare Chicago Illinois USA
Both components are marked for conformity within the European Union CE The entire system including the probe and scanner system would classify as a Class IIa medical device but it has not gone through a notified body as the system is not intended for commercial use
For measurements the participant is placed on a bed and scanned with conventional ultrasound to locate the region of tendon injury or the thickest part of the tendon for healthy participants and characterize it with grey-scale and Doppler imaging The region of interest is marked on the skin and the ultrasound probe is affixed to the tendon at the specified location using a custom holder to minimize motion The probe is then be disconnected from the conventional ultrasound scanner and connected to the Vantage 256 scanner to record SURE images Image data may be collected for up to 1 minute Two scans at the same location are used for estimating repeatability The imaging setup and image processing will be adjusted to maximize quality of the SURE images From the images the vessel density and potentially other parameters flow rate flow orientation vessel dimensions etc may be determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 854796 | OTHER_GRANT | European Research Council Synergy Grant | None |