Ultrasound Analysis for Lymphedema

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, Inability to consent, Surgery, others

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

Compensation: Varies

Number of Visits: 1

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Researchers are trying to validate the use of ultrasound sub-hertz analysis of viscoelastisty (SAVE) method to monitor tissue-fluid dynamics and stage disease severity in patients diagnosed with lymphedema.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the SAVE Method treatment for lymphedema?

Research shows that ultrasound elastography, a technique similar to the SAVE Method, can effectively identify changes in tissue properties in lymphedema patients, suggesting its potential usefulness in assessing and managing the condition. ^{1 2 3 4 5}

Is ultrasound elastography safe for use in humans?

Ultrasound elastography is considered safe for use in humans as it is a non-invasive imaging technique that has been used in various studies to assess conditions like lymphedema without reported safety concerns. ^{1 2 4 5 6}

How does the SAVE Method treatment for lymphedema differ from other treatments?

The SAVE Method is unique because it uses ultrasound to analyze the viscoelastic properties (how tissues stretch and return to shape) of affected tissues, providing a more objective assessment compared to traditional methods that rely on manual examination. This approach can help in better detecting and staging lymphedema by identifying changes in tissue mechanics that are not visible in standard ultrasound images. ^{1 2 6 7 8}

Research Team

Antonio Forte, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults over 18 who have been diagnosed with lymphedema and can give written consent. It's not open to those under 18, anyone unable to consent, or patients who've had certain surgeries like lymphovenous bypass or lymph node transfer.

Inclusion Criteria

Ability to provide written consent

I have been diagnosed with Lymphedema.

Exclusion Criteria

Inability to provide written consent

I am under 18 years old.

I have had surgery to improve lymph flow.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline viscoelasticity parameters are collected using the SAVE method

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in viscoelasticity parameters

4 weeks

Treatment Details

Interventions

• Sub-Hertz Analysis of Viscoelasticity (SAVE) Method

Trial Overview The study is testing a new ultrasound technique called SAVE that measures how fluid moves in tissues and helps determine the severity of lymphedema. Researchers want to see if this method is effective for monitoring the condition.

Participant Groups

Group I: Affected (Lymphedema) Experimental Treatment 1 Intervention

Subjects affected lymphedema extremity will have elastic and viscoelastic parameters collected by ultrasound procedure

Group II: Unaffected (Control) Active Control 1 Intervention

Subjects unaffected extremity will have elastic and viscoelastic parameters collected by ultrasound procedure

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The study successfully demonstrated that free-hand real-time tissue elastography (RTE) can be used to measure strains in skin and subcutaneous tissue, showing significant differences in strain between healthy tissue in 35 volunteers.

In patients with unilateral stage II lymphedema, the study found no significant differences in strain measurements between the affected and unaffected legs, suggesting that lymphedema may not alter the mechanical properties of the skin and subcutaneous tissue as measured by RTE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time tissue elastography assessment of skin and subcutaneous tissue strains in legs with lymphedema. Suehiro, K., Nakamura, K., Morikage, N., et al.[2018]

The DermaScan C high frequency ultrasound demonstrated excellent intra-rater reliability for measuring dermal echogenicity in both people with primary lymphoedema (PLO) and those without lymphoedema (NLO), indicating it is a reliable tool for assessing skin properties.

Inter-session reliability was moderate in NLO but improved significantly in PLO after method adjustments, suggesting that careful calibration and technique are crucial for consistent results in different patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermal thickness and echogenicity using DermaScan C high frequency ultrasound: Methodology and reliability testing in people with and without primary lymphoedema. Phillips, J., Reynolds, KJ., Gordon, SJ.[2021]

References

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

Assessment of Mechanical Properties of Tissue in Breast Cancer-Related Lymphedema Using Ultrasound Elastography. [2020]

2. Japan pubmed.ncbi.nlm.nih.gov

Real-time tissue elastography assessment of skin and subcutaneous tissue strains in legs with lymphedema. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of Ultrasound and Shear Wave Elastography for the Diagnosis of Breast Cancer-Related Lymphedema. [2021]

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

Ultrasound Vibroelastography for Evaluation of Secondary Extremity Lymphedema: A Clinical Pilot Study. [2021]

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

Ultrasound Elastography Use in Lower Extremity Lymphedema: A Systematic Review of the Literature. [2020]

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

Dermal thickness and echogenicity using DermaScan C high frequency ultrasound: Methodology and reliability testing in people with and without primary lymphoedema. [2021]

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

Nonlinear viscoelastic properties of tissue assessed by ultrasound. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The spatio-temporal strain response of oedematous and nonoedematous tissue to sustained compression in vivo. [2016]