Super-resolution Ultrasound Imaging for Chronic Kidney Disease

This trial aims to evaluate the effectiveness of a special type of ultrasound imaging, called super-resolution ultrasound imaging, for individuals with Chronic Kidney Disease (CKD). The method uses an ultrasound contrast agent called Definity, already approved for other organs, to capture clear images of the kidneys. The study includes two groups: CKD patients requiring a kidney biopsy and healthy volunteers. Individuals with CKD undergoing a kidney biopsy or healthy individuals may participate. Those with a history of allergic reactions to ultrasound contrast agents or serious heart problems may not be eligible. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Studies have shown that Lumason, the ultrasound contrast agent used in this trial, is generally well-tolerated. The FDA has already approved it for use in the heart, liver, and urinary tract. Research indicates that patients who received Lumason experienced very low rates of serious issues. Specifically, the death rate was only 0.03%, which was lower than in those who didn't receive any ultrasound contrast agent.

However, serious heart and lung reactions, including deaths, have occurred, although these are uncommon. This means that while the risk is low, it remains a consideration.

Researchers are excited about this trial because it uses Super-Resolution Ultrasound Imaging (SRUI) with the Definity ultrasound contrast agent to capture detailed images of kidney microvessels. Unlike standard imaging techniques, which might not clearly visualize tiny blood vessels in the kidneys, SRUI offers high-resolution images that could provide new insights into chronic kidney disease (CKD). This technique has the potential to improve diagnosis and understanding of CKD by offering a more precise view of kidney health.

Research has shown that Lumason, a special dye used in ultrasound scans, helps doctors see kidney problems more clearly. It distinguishes between solid tumors and complex cysts in the kidneys. Lumason enhances ultrasound images without much strain on the body. Although primarily used for the heart, liver, and urinary tract, it also shows promise for kidney imaging. In this trial, Lumason will obtain super-resolution ultrasound images for subjects with chronic kidney disease and healthy volunteers. These findings suggest Lumason could improve ultrasound imaging for chronic kidney disease detection.¹⁶⁷⁸⁹