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

Trial Summary

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 data supports the effectiveness of the treatment Shear Wave Elastography for post-surgery kidney assessment?

Research shows that Shear Wave Elastography (SWE) can help assess kidney stiffness and detect kidney issues like fibrosis (scarring) and differentiate between benign and malignant kidney masses. This suggests it could be useful for monitoring kidney health after surgery. ^{1 2 3 4 5}

Is shear wave elastography safe for use in humans?

Shear wave elastography (SWE) is generally considered safe for use in humans, as it is a non-invasive imaging technique used in various studies, including those on kidney and breast conditions. While specific safety data for post-surgery kidney assessment is limited, SWE has been used safely in other medical contexts. ^{1 2 6 7 8}

How is shear wave elastography different from other treatments for post-surgery kidney assessment?

Shear wave elastography (SWE) is unique because it uses sound waves to measure the stiffness of kidney tissue, which can help assess kidney health after surgery. Unlike other methods, SWE is non-invasive and provides real-time imaging, making it a novel approach for evaluating kidney conditions without the need for a biopsy. ^{2 3 4 9 10}

What is the purpose of this trial?

In this exploratory study we explore the use of Shear Wave Elastography to differentiate between Acute Kidney Injury after vascular surgery and among the healthy population.

Research Team

Ahmed Zaky, MD, MPH

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 (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]

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) 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 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]

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Predicting Progression of Kidney Injury Based on Elastography Ultrasound and Radiomics Signatures. [2023]

2. United States 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. [2022]

3. Romania pubmed.ncbi.nlm.nih.gov

Value of Shear Wave Elastography for differentiating benign and malignant renal lesions. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Shear wave elastography using high-frequency linear probe for kidney transplant monitoring: A methodological study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Shear Wave Elastography in the Evaluation of the Kidneys in Pediatric Patients with Unilateral Vesicoureteral Reflux. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Shear Wave Elastographic Alterations in the Kidney After Extracorporeal Shock Wave Lithotripsy. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Improved Breast 2D SWE Algorithm to Eliminate False-Negative Cases. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Reliability of shear wave ultrasound elastography for neck lesions identified in routine clinical practice. [2016]

9. Germany pubmed.ncbi.nlm.nih.gov

Quantitative elastography of renal transplants using supersonic shear imaging: a pilot study. [2022]

10. England 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. [2018]