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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the relationship between transdiaphragmatic pressure (Pdi) and diaphragm shear-wave elastography (SWE) during state-of-the-art respiratory muscle testing including volitional efforts (e.g., maximal inspiratory pressure, maximal expiratory pressure, Valsalva maneuver), as well as maximal phrenic nerve stimulation.

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 data supports the effectiveness of the treatment Shear-wave Elastography for respiratory complications?

Shear-wave Elastography (SWE) is a technique that uses ultrasound to measure tissue stiffness, and it has been shown to be effective in differentiating between benign and malignant conditions in thyroid and breast tissues, as well as measuring scar stiffness. This suggests that SWE could potentially be useful in assessing tissue changes related to respiratory complications. ^{1 2 3 4 5}

Is shear-wave elastography safe for use in humans?

Shear-wave elastography (SWE) is a non-invasive ultrasound technique used in various studies, including those on neck lesions, lung lesions, burn scars, and other conditions. It is generally considered safe for human use, as it involves no radiation and is similar to standard ultrasound procedures. ^{2 3 5 6 7}

How does shear-wave elastography differ from other treatments for respiratory complications?

Shear-wave elastography (SWE) is unique because it uses ultrasound technology to measure tissue stiffness, which can help in characterizing lung lesions. Unlike traditional imaging methods, SWE provides quantitative data on tissue elasticity, potentially offering more precise information about respiratory complications. ^{2 4 6 8 9}

Research Team

Carlos Matilla, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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) 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 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) 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]

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 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]

References

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

Shear wave elastography: a new ultrasound imaging mode for the differential diagnosis of benign and malignant thyroid nodules. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Objective quantification of burn scar stiffness using shear-wave elastography: Initial evidence of validity. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

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

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

Clinical application of shear wave elastography (SWE) in the diagnosis of benign and malignant breast diseases. [2022]

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

Shear wave elastography evaluation of testes with non-communicating hydrocele in infants and toddlers: A preliminary study. [2019]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Transthoracic ultrasound shear wave elastography for the study of subpleural lung lesions. [2022]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Evaluation of Ovaries in Patients with Polycystic Ovary Syndrome using Shear Wave Elastography. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Liver fibrosis evaluation using real-time shear wave elastography: applicability and diagnostic performance using methods without a gold standard. [2019]

9. Italy pubmed.ncbi.nlm.nih.gov

Role of shear wave elastography ultrasound in patients with systemic sclerosis. [2023]