Ultrasound Imaging Technology for Kidney Stones

Overseen By Barbrina Dunmire

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Systemic disease, Renal disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using ultrasound technology to better detect and measure kidney stones. Researchers aim to determine if the Verasonics Data Acquisition System (VDAS) can enhance the visualization and sizing of kidney stones in ultrasound images. Individuals with kidney stones visible on x-rays and who have recently undergone a CT scan may qualify for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve kidney stone diagnosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this ultrasound imaging technology is safe for detecting kidney stones?

Research shows that the Verasonics Data Acquisition System (VDAS) is commonly used in medical imaging research. Although not primarily for diagnosing illnesses, it serves as a reliable tool for research at many institutions. The VDAS meets FDA safety standards, ensuring its safe use in studies.

No specific reports of negative effects linked to the VDAS have been found. It is important to note that the VDAS is designed for research, having undergone safety testing in controlled settings. While direct safety data from patient studies is lacking, its widespread use in research worldwide suggests it is safe.

For those considering participation in a trial using the VDAS, this information should provide reassurance about its safety in human studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Verasonics Data Acquisition System (VDAS) because it offers a new approach to imaging kidney stones using advanced ultrasound technology. Unlike traditional imaging methods like CT scans or standard ultrasounds, the VDAS uses modified image processing to potentially provide more precise information about the size and location of kidney stones while staying within FDA safety limits. This could lead to more accurate diagnoses and better treatment planning, reducing the need for invasive procedures or excessive radiation exposure.

What evidence suggests that this ultrasound imaging technology is effective for detecting kidney stones?

Research shows that the Verasonics Data Acquisition System (VDAS), used to image participants in this trial, can accurately measure kidney stones with advanced ultrasound methods. Studies have found that this system employs superior image processing to detect and measure kidney stones more precisely. As a result, doctors can see the stone's size and location more clearly. Early results suggest it might also help move stones to less troublesome areas in the kidney. The technology is designed to be safe and aims to improve the accuracy of ultrasound imaging for kidney stones. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Bailey

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 21 who have kidney stones visible on x-ray and can consent to participate. They must also have a recent CT scan. It's not for those under 21, unable to consent, with stones invisible on x-ray, or with certain systemic diseases or renal disorders.

Inclusion Criteria

Able to give informed consent

I am 21 years old or older.

You have kidney stones that can be seen on an x-ray.

Exclusion Criteria

Stones that cannot be seen on an x-ray.

I am under 21 years old.

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging Procedure

Participants undergo ultrasound imaging to determine the size and location of kidney stones using the Verasonics Data Acquisition System (VDAS)

1 day

1 visit (in-person)

Data Analysis

Comparison of research ultrasound data with clinical data to assess accuracy

2 weeks

Follow-up

Participants are monitored for any additional data collection from existing medical records

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Verasonics Data Acquisition System (VDAS)

Trial Overview The study tests if new software that processes ultrasound images can better detect and size kidney stones using the Verasonics Data Acquisition System (VDAS).

How Is the Trial Designed?

Group I: Kidney stones Experimental Treatment 1 Intervention

Device: Verasonics Data Acquisition System (VDAS) Other Names: Verasonics Data Acquisition System (VDAS) Verasonics Ultrasound Engine Subjects will be imaged the Verasonics Data Acquisition System (VDAS) using conventional clinical outputs within FDA limits. The image processing has been modified. Subjects in this arm will be imaged by ultrasound by the VDAS. Stone location and size will be determined and compared to clinical determination of stone location and size.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Measuring the acoustic shadow behind kidney stones provides a more accurate estimation of their size compared to direct measurements, with an average error of only 0.0 ± 0.8 mm for shadow width across different ultrasound modalities.

Among the ultrasound imaging techniques tested, harmonic imaging was found to be the most accurate for measuring stone size, while the accuracy of stone width measurements decreased with greater imaging depth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Acoustic Shadow Width to Determine Kidney Stone Size with Ultrasound. Dunmire, B., Harper, JD., Cunitz, BW., et al.[2022]

In a study of 210 patients with hydronephrosis, urinary stones were identified as the cause in 60% of cases, highlighting their significant role in this condition.

The detection rate of urinary stones increased with the severity of hydronephrosis, with rates of 50% for Grade 1, 61% for Grade 2, and 71.4% for Grade 3, but decreased in Grade 4, indicating a complex relationship between hydronephrosis severity and stone detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between grades of Hydronephrosis and detection of urinary stones by ultrasound imaging. Alshoabi, SA.[2022]

Ultrasonography (US) demonstrated a sensitivity of 70.0% and specificity of 94.4% for detecting renal stones when compared to noncontrast enhanced computed tomography (NCCT), indicating it is a reliable imaging option.

US was particularly effective in detecting larger stones, with a higher detection rate for stones in other locations compared to the left upper calyx, and showed a strong correlation in size measurements with NCCT in 72% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of ultrasonography for the detection of renal stone. Kanno, T., Kubota, M., Sakamoto, H., et al.[2022]

The study involving 34 subjects and 115 renal stones found that the S-mode ultrasound technique accurately detected 84% of stones identified by CT, with 73% of stone size measurements within 2 mm of CT measurements.

S-mode ultrasound provided better visualization and sizing of kidney stones compared to a standard clinical ultrasound system, with measurements differing from CT by only 1.6 mm for stones and 0.8 mm for shadows, indicating its potential for improved clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stone-Mode Ultrasound for Determining Renal Stone Size. May, PC., Haider, Y., Dunmire, B., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4507572/

Ultrasonic propulsion of kidney stones: preliminary results ... Reported here are preliminary findings from the first investigational use of UP in humans. The device uses a Verasonics ultrasound engine and Philips HDI C5-2 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02214836

Ultrasound Imaging of Kidney Stones and Lithotripsy | ... Subjects will be imaged the Verasonics Data Acquisition System (VDAS) using conventional clinical outputs within FDA limits. The image processing has been ...

3. withpower.com withpower.com/trial/phase-calculi-9-2014-40fc6

Ultrasound Imaging Technology for Kidney Stones The Verasonics Data Acquisition System (VDAS) is unique because it uses advanced ultrasound imaging techniques to accurately size kidney stones, which is a ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4414252/

Focused Ultrasound to Expel Calculi from the Kidney Focused ultrasound has the potential to expel small stones or residual stone fragments from the kidney, or move obstructing stones to a nonobstructing location.

5. ctv.veeva.com ctv.veeva.com/study/ultrasound-imaging-of-kidney-stones-and-lithotripsy

Ultrasound Imaging of Kidney Stones and Lithotripsy The purpose of this study is to determine whether new software processing of ultrasound images can improve detection and size determination ...

6. verasonics.com verasonics.com/

Verasonics - The Leader in Research Ultrasound Verasonics' Vantage ultrasound systems are used today at numerous institutions and companies worldwide for FUS research and product development.

7. verasonics.com verasonics.com/wp-content/uploads/2024/02/Vantage-Solution-Biomedical-Brochure-Feb-2024.pdf

The Vantage® Systems The system is intended to be used as a research laboratory tool to acquire, store, display and analyze data. It is not a diagnostic ultrasound system.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6467760/

Real-time H-scan ultrasound imaging using a Verasonics ... The system contains three receive buffers to receive the RF data transferred from the local memories on the Verasonics Data Acquisition System (VDAS) modules.

9. verasonics.com verasonics.com/vantage-systems/

Vantage Research Ultrasound System Verasonics offers a state-of-the-art programmable ultrasonic research system for advanced medical imaging and research.

10. verasonics.com verasonics.com/wp-content/uploads/2019/04/Vantage-Systems-Brochure.pdf

The Vantage™ Systems The system is designed for ultrasound research rather than routine diagnostic use. • It is intended to be used as a research laboratory tool to acquire, store, ...