Shear Wave Elastography Imaging for Post-Surgery Kidney Assessment

Overseen By Ayesha Bryant, MD, MSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: End stage renal, heart disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 96 hours

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique called Shear Wave Elastography to determine if it can differentiate between kidney issues after vascular surgery and healthy kidneys. The goal is to help doctors better understand and identify acute kidney injuries. Participants include individuals with normal kidney function, no history of diabetes or high blood pressure, and a normal body weight. Those who have had vascular surgery and meet these criteria might be suitable to help advance kidney care. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve kidney care for future patients.

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 Shear Wave Elastography is safe for post-surgery kidney assessment?

Research has shown that Shear Wave Elastography (SWE) is generally safe. As a non-invasive imaging method, it does not involve surgery or entering the body. Studies have used SWE to examine various kidney conditions without harmful side effects, indicating it is well-tolerated. Researchers have tested SWE on diverse groups, including individuals with kidney disease and children, and it has effectively measured kidney stiffness and changes. These studies have found no major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Shear Wave Elastography because it's a cutting-edge imaging technique that provides a non-invasive way to assess kidney health after surgery. Unlike traditional methods that often require biopsies or contrast imaging, this technique uses sound waves to measure tissue stiffness, which can give insights into potential complications without needing surgery. This approach can lead to faster, safer evaluations, helping doctors make better decisions on post-surgery care.

What evidence suggests that Shear Wave Elastography is effective for assessing post-surgery kidney conditions?

Research has shown that Shear Wave Elastography (SWE) effectively checks kidney health. One study found that SWE reliably measures kidney stiffness in transplant patients, aiding in health assessment. Another study discovered that SWE surpasses traditional methods, such as measuring kidney size, in detecting chronic kidney disease. Additionally, SWE effectively differentiates kidney conditions by measuring elasticity. This trial will compare SWE assessments in two groups: healthy controls and vascular surgery subjects. These findings suggest that SWE may help distinguish between Acute Kidney Injury after surgery and healthy kidneys. ^{1 2 4 6 7}

Who Is on the Research Team?

Ahmed Zaky, MD, MPH

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults with healthy kidneys, normal kidney function (eGFR > 60 ml/min/m^2), and a BMI under 27 kg/m^2. It's not for those with diabetes or hypertension, prisoners from correctional facilities, transplant or ventricular assist device patients, children under 19 years old or weighing less than 50 kg if age is unknown.

Inclusion Criteria

Your kidney function, measured by the estimated glomerular filtration rate, is above a certain level.

My kidneys are normal on ultrasound.

I have never had diabetes or high blood pressure.

Exclusion Criteria

You have a condition that makes it difficult to see your kidneys with ultrasound.

My upcoming procedure does not involve vascular surgery.

I have severe kidney problems or am on dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo Shear Wave Elastography to assess kidney function

96 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Shear Wave Elastography

Trial Overview The study investigates the use of Shear Wave Elastography—a type of ultrasound—to tell apart Acute Kidney Injury in individuals after vascular surgery from that in healthy people.

How Is the Trial Designed?

Group I: Vascular Surgery Subjects Experimental Treatment 1 Intervention

Group II: Healthy Controls Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Shear wave elastography (SWE) using a high-frequency probe is effective for evaluating transplanted kidneys, showing good reproducibility with intra- and interobserver agreement scores of 0.85 and 0.77, respectively.

Factors such as skin-allograft distance and kidney width significantly influence the quality of SWE images, with better quality observed in kidneys less than 5.4 cm wide and closer to the skin surface.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shear wave elastography using high-frequency linear probe for kidney transplant monitoring: A methodological study. Yang, D., Zhuang, B., Zheng, Y., et al.[2023]

Shear-wave elastography (SWE) demonstrated significant differences in elasticity values between malignant (27.27±25.66 kPa) and benign (16.13±8.89 kPa) kidney masses, indicating its potential as a diagnostic tool for assessing kidney tumors.

The study suggests that SWE is a noninvasive method that can provide valuable quantitative information about tissue elasticity, although further research with larger groups is needed to better understand the factors influencing SWE values.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of Shear Wave Elastography for differentiating benign and malignant renal lesions. Aydin, S., Yildiz, S., Turkmen, I., et al.[2018]

A study involving 43 kidney transplant recipients demonstrated that supersonic shear imaging (SSI) can reliably measure renal cortical stiffness, which is expressed in Young's modulus (kPa).

The level of cortical stiffness measured by SSI showed a significant correlation with the total Banff scores of chronic lesions in the kidney, indicating that this non-invasive method can help assess the overall histological health of transplanted kidneys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative elastography of renal transplants using supersonic shear imaging: a pilot study. Grenier, N., Poulain, S., Lepreux, S., et al.[2022]

In a study involving 32 rabbit kidneys and 6 beagle kidneys, it was found that renal perfusion status significantly affects the elasticity measurements of different kidney compartments, with the cortex showing the highest elasticity and being most sensitive to changes in perfusion.

The study demonstrated that elasticity values increased with renal vein ligation and decreased with renal artery stenosis, highlighting the importance of considering both kidney structure and blood flow when using shear wave elastography (SWE) for evaluating renal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of renal perfusion and structural heterogeneity on shear wave elastography of the kidney: an in vivo and ex vivo study. Liu, X., Li, N., Xu, T., et al.[2018]

The updated 2D shear wave elastography (SWE) algorithm significantly improves the sensitivity for detecting breast lesions, increasing from 45% to 100% compared to the standard algorithm, while still maintaining a high negative predictive value of 100%.

This new algorithm also helps to reduce false-negative results associated with 'soft' cancer artifacts, allowing for more accurate characterization of breast lesions and the potential to downgrade all BI-RADS 4 lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Breast 2D SWE Algorithm to Eliminate False-Negative Cases. Barr, RG., Engel, A., Kim, S., et al.[2023]

Shear wave elastography (SWE) was able to detect renal scar formation in patients with vesicoureteral reflux (VUR), showing significantly higher shear wave velocity (SWV) values in kidneys with scarring compared to normal kidneys.

Despite its ability to identify scar tissue, the variability in kidney stiffness due to its complex structure and factors like blood flow may limit the clinical application of SWE in diagnosing VUR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shear Wave Elastography in the Evaluation of the Kidneys in Pediatric Patients with Unilateral Vesicoureteral Reflux. Kalyoncu Ucar, A., Cicek, RY., Alis, D., et al.[2019]

In a study of 124 chronic kidney disease (CKD) patients, shear wave elastography (SWE) effectively measured renal stiffness, showing that elasticity values decreased significantly with increasing severity of kidney impairment, particularly distinguishing moderate to severe cases from mild ones.

The Emax parameter from SWE demonstrated the best ability to differentiate between levels of kidney damage, with a notable area under the curve (AUC) of 0.764, suggesting that SWE could be a valuable tool for assessing renal fibrosis in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of renal fibrosis in patients with chronic kidney disease by shear wave elastography: a comparative analysis with pathological findings. Chen, Z., Chen, J., Chen, H., et al.[2022]

Shear wave elastography ultrasound (SWE) has been identified as a promising non-invasive method for predicting kidney injury progression, with a specific median SWE value indicating risk for patients with stage 3 or higher kidney disease.

The study, which followed 187 kidney biopsy patients for an average of about 25 months, found that incorporating radiomics signatures from SWE images significantly enhanced the predictive accuracy of traditional models for kidney prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Progression of Kidney Injury Based on Elastography Ultrasound and Radiomics Signatures. Zhu, M., Tang, L., Yang, W., et al.[2023]

In a study of 59 patients undergoing extracorporeal shock wave lithotripsy (ESWL) for kidney stones, significant changes in renal tissue stiffness were observed immediately after treatment, indicating temporary alterations in kidney tissue.

Both shear wave elastography (SWE) and resistive index (RI) values showed significant changes 1 hour post-treatment, but returned to baseline levels after one week, suggesting that while ESWL causes short-term effects on kidney tissue, these effects are not permanent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shear Wave Elastographic Alterations in the Kidney After Extracorporeal Shock Wave Lithotripsy. Turkay, R., Inci, E., Bas, D., et al.[2018]

Shear wave ultrasound elastography (SWE) demonstrated fair to excellent reliability in assessing neck lesions, with intraclass correlation coefficients (ICCs) ranging from 0.78 to 0.85 for a radiologist evaluating 176 lesions, indicating it can be a dependable tool for diagnosis.

The reliability of SWE was influenced by the type of tissue, showing higher agreement in thyroid lesions compared to lymph nodes, and was better for benign lesions than malignant ones, suggesting that further research is needed to establish clinically acceptable stiffness values for different neck tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of shear wave ultrasound elastography for neck lesions identified in routine clinical practice. Bhatia, K., Tong, CS., Cho, CC., et al.[2016]

Citations

1. withpower.com withpower.com/trial/phase-acute-kidney-injury-2020-f4ca5

Shear Wave Elastography Imaging for Post-Surgery Kidney ... A study involving 43 kidney transplant recipients demonstrated that supersonic shear imaging (SSI) can reliably measure renal cortical stiffness, which is ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6223162/

Shear wave elastography in the evaluation of renal ... SWE was superior to renal length and cortical thickness in detecting CKD. A value of 4.31 kPa or less showed good accuracy in determining whether a kidney was ...

3. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-025-02070-x

Shear wave elastography for assessing kidneys in pediatric ... Our results demonstrated a significant difference in renal elasticity, with the nephrotic syndrome group exhibiting a mean shear wave velocity ( ...

4. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/00368504251363483

Integrative evaluation of shear wave elastography and ... We hypothesize that combining point shear wave elastography (PSWE) with clinical risk factors enables accurate renal fibrosis assessment.

5. annalsoftransplantation.com annalsoftransplantation.com/abstract/full/idArt/945699

Predictive Model for Post-Transplant Renal Fibrosis Using ... The aim of this study was to investigate the clinical utility of ultrasound shear wave elastography (SWE) for assessment of renal fibrosis in post-renal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10078884/

Ultrasound shear wave elastography for the evaluation of ... This study reviews the use of SWE to evaluate pathological changes in native kidneys and renal allografts. It also tries to elucidate the confounding factors ...

7. umbjournal.org umbjournal.org/article/S0301-5629(18)30277-1/fulltext

Supersonic Shear Wave Ultrasonography for Assessing ... Our results highlight a positive correlation between increased cortical stiffness and presence of CKD. Further studies are needed to validate this method for ...