SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Tendinopathic Tendons

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.