Shear-wave Elastography for Respiratory Complications

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, COPD, Asthma, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the relationship between diaphragm stiffness, measured using shear-wave elastography (an ultrasound-based imaging method), and breathing pressures during various breathing tests. The focus is on understanding the diaphragm's role in breathing, which could improve treatments for respiratory issues. Participants will undergo standard breathing tests and ultrasound-based measurements. Healthy adults without lung problems such as asthma or COPD are ideal candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future respiratory treatments.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, if you have a pulmonary condition like COPD or asthma that requires routine treatment, you would not be eligible to participate.

What prior data suggests that shear-wave elastography is safe for respiratory function testing?

Research has shown that shear-wave elastography (SWE) is a safe and reliable method. This technique uses ultrasound to assess tissue stiffness, aiding doctors in diagnosing lung issues. Studies have found that SWE is noninvasive, as it does not involve surgery or entering the body, making it a gentle choice for patients. No major safety concerns have been reported with this technique. Patients have tolerated it well, and it is considered a cost-effective way to evaluate lung health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional respiratory function tests that rely on spirometry or blood gas analysis, shear-wave elastography offers a non-invasive way to assess lung health by measuring tissue stiffness using ultrasound waves. This technique allows for real-time monitoring of lung conditions without the need for invasive procedures. Researchers are excited about shear-wave elastography because it has the potential to provide more detailed and dynamic insights into lung function, which could lead to earlier detection and better management of respiratory complications.

What evidence suggests that shear-wave elastography is effective for respiratory complications?

Research has shown that shear-wave elastography (SWE) effectively measures diaphragm stiffness, aiding in lung health assessment. Studies have found that SWE can distinguish between different tissue types, such as cancerous and non-cancerous lumps, which is useful for identifying breathing problems. It has been used in conditions like COPD, a lung disease that makes breathing difficult, to examine diaphragm changes. Current evidence suggests it could serve as a reliable tool for diagnosing and managing lung issues through non-invasive imaging. In this trial, all participants will undergo standard respiratory function testing along with ultrasound-based elastography measurements to evaluate its effectiveness in various conditions. ^{3 5 6 7 8}

Who Is on the Research Team?

Carlos Matilla, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adult men and women who are generally healthy. It's not suitable for pregnant individuals or those with known lung problems like COPD or asthma that needs regular treatment.

Inclusion Criteria

I am a healthy adult.

Exclusion Criteria

Volunteers who are pregnant.

I have a lung condition like COPD or asthma that needs regular treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Respiratory Function Testing

Participants undergo standard respiratory function testing and ultrasound-based elastography measurements

3 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Shear-wave Elastography

Trial Overview The study is testing how well shear-wave elastography, a type of ultrasound, can measure diaphragm muscle function compared to traditional respiratory tests during various breathing maneuvers and nerve stimulation.

How Is the Trial Designed?

Group I: Respiratory Function Testing Experimental Treatment 1 Intervention

All subjects will receive standard respiratory function testing and ultrasound-based elastography measurements across various behaviors and conditions

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Shear wave elastography (SWE) effectively measures skin stiffness and thickness in patients with systemic sclerosis (SSc), showing that SSc patients have significantly thicker skin (1.74 mm) and higher stiffness (47.32 kPa) compared to healthy controls (1.5 mm and 19.5 kPa).

SWE demonstrates a strong correlation with clinical assessments of skin involvement, making it a reliable and safe technique for diagnosing and monitoring skin changes in scleroderma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of shear wave elastography ultrasound in patients with systemic sclerosis. Tumsatan, P., Uscharapong, M., Srinakarin, J., et al.[2023]

Shear wave elastography (SWE) demonstrated a significant ability to differentiate between malignant and benign nodules, with a mean elasticity index of 150 kPa for malignant nodules compared to 36 kPa for benign ones, indicating its potential as a reliable diagnostic tool.

SWE showed a high specificity of 93.9% and a sensitivity of 85.2% at a cutoff of 65 kPa, outperforming traditional ultrasound (US) methods, which had a lower sensitivity of 51.9%, suggesting that SWE could enhance the accuracy of malignancy predictions in thyroid nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shear wave elastography: a new ultrasound imaging mode for the differential diagnosis of benign and malignant thyroid nodules. Sebag, F., Vaillant-Lombard, J., Berbis, J., et al.[2022]

Real-time shear wave elastography (SWE) demonstrated a good performance for diagnosing cirrhosis, with specificity at 99% and sensitivity ranging from 47% to 64%, making it comparable to other fibrosis biomarkers like FibroTest (FT) and liver stiffness measurement (LSM).

SWE had a lower applicability rate (90.0%) compared to FT (97.9%), but it performed better in patients with ascites, indicating its potential usefulness in specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver fibrosis evaluation using real-time shear wave elastography: applicability and diagnostic performance using methods without a gold standard. Poynard, T., Munteanu, M., Luckina, E., et al.[2019]

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]

Shear wave elastography (SWE) effectively measures the elasticity of testicular tissues, revealing that testes with non-communicating hydrocele in infants and toddlers have significantly higher elasticity values compared to controls without hydrocele, despite no difference in testicular volumes.

The study suggests that non-communicating hydrocele may negatively impact testicular tissue, indicating a need for re-evaluation of surgical intervention timing in affected children, as SWE could potentially replace more invasive procedures like testicular biopsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shear wave elastography evaluation of testes with non-communicating hydrocele in infants and toddlers: A preliminary study. Kocaoglu, C., Durmaz, MS., Sivri, M.[2019]

Shear wave elastography (SWE) demonstrated significantly higher elasticity values in malignant breast masses (average 153.3 kPa) compared to benign masses (average 46.1 kPa), indicating its potential for effective differentiation between the two types of lesions.

SWE showed a high diagnostic performance with a sensitivity of 88.8% and specificity of 84.9%, outperforming conventional ultrasound, and suggesting that it could be a valuable tool in breast cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of shear wave elastography (SWE) in the diagnosis of benign and malignant breast diseases. Chang, JM., Moon, WK., Cho, N., et al.[2022]

Shear-wave elastography (SWE) effectively measures the stiffness of burn scars, showing high correlations with established scar assessment scales, indicating its potential as a reliable tool for evaluating scar properties.

Factors such as the time since the burn injury, gender, body location, and skin type significantly influence the measurements of scar stiffness, suggesting that these patient characteristics should be considered when interpreting SWE results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective quantification of burn scar stiffness using shear-wave elastography: Initial evidence of validity. DeJong, H., Abbott, S., Zelesco, M., et al.[2021]

Shear wave elastography (SWE) was tested on 190 patients with subpleural lung lesions and found to be ineffective in distinguishing between lung malignancies and pneumonia, as well as different types of lung cancer.

The study revealed that pneumonia had higher stiffness than lung carcinomas when excluding necrotic lesions, but overall, SWE could not resolve the clinical challenges associated with chronic subpleural consolidations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transthoracic ultrasound shear wave elastography for the study of subpleural lung lesions. Quarato, CMI., Venuti, M., Dimitri, L., et al.[2022]

In a study involving 138 women (66 with PCOS and 72 controls), shear wave electrography (SWE) was used to assess ovarian elasticity, but no significant differences in elasticity or velocity were found between the PCOS and non-PCOS groups.

Despite differences in other clinical characteristics like BMI and hormone levels, SWE did not show distinct elasticity properties in the ovaries of patients with PCOS, suggesting that this imaging technique may not be effective for diagnosing or evaluating ovarian conditions in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Ovaries in Patients with Polycystic Ovary Syndrome using Shear Wave Elastography. Altunkeser, A., Inal, ZO., Baran, N.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9686016/

Two-dimensional shear wave elastography: a new tool for ... In this study, two-dimensional shear wave elastography (2D-SWE) was used to measure diaphragm stiffness (DS) and intercostal muscle stiffness (IMS) in patients ...

2. withpower.com withpower.com/trial/shear-wave-elastography-for-respiratory-complications-f1c6a

Shear-wave Elastography for Respiratory Complications Shear wave elastography (SWE) demonstrated a significant ability to differentiate between malignant and benign nodules, with a mean elasticity index of 150 kPa ...

3. publications.ersnet.org publications.ersnet.org/content/erjor/10/4/00081-2024

Current evidence for lung ultrasound elastography in the field ... The currently available literature indicates that pleuropulmonary ultrasound elastography produces promising and consistent results.

4. ejb.springeropen.com ejb.springeropen.com/articles/10.1186/s43168-025-00408-z

Transthoracic ultrasound shear-wave elastography: can it play ... Transthoracic shear-wave ultrasound elastography can be applied as a promising tool for assessing unidentified and difficult-to-diagnose peripheral lung ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jum.15655

Ultrasound Shear Wave Elastography for Evaluation of ... This study explores the feasibility of ultrasound shear wave elastography (SWE) to measure diaphragmatic stiffness and evaluates its changes in COPD patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8696150/

Transthoracic ultrasound shear wave elastography for the ... The aim of this study was to assess whether new-generation shear wave elastography (SWE) is suitable for the characterization of lung subpleural lesions.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8544928/

Ultrasound Elastography for Lung Disease Assessment - PMC Ultrasound elastography (US-E) is a noninvasive, safe, cost-effective and reliable technique to assess the mechanical properties of soft tissue.

8. mdpi.com mdpi.com/2075-4418/15/2/225

Diagnostic Accuracy of Shear Wave Elastography in ... The incorporation of shear wave elastography (SWE) represents a possible tool in stratifying pleural effusions by the risk of underlying malignancy.