Ultrasound Analysis for Lymphedema

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new way to use ultrasound to monitor and understand lymphedema, a condition where excess fluid collects in tissues and causes swelling. Researchers are testing a method called Sub-Hertz Analysis of Viscoelasticity (SAVE) to determine if it can effectively measure fluid movement through tissues and assess disease severity. The study involves two groups: one with a limb affected by lymphedema and one without. Individuals diagnosed with lymphedema who have not undergone certain lymphatic surgeries might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve lymphedema monitoring and treatment.

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 prior data suggests that the SAVE method is safe for monitoring lymphedema?

Research shows that the Sub-Hertz Analysis of Viscoelasticity (SAVE) method uses ultrasound to assess how tissues stretch and bounce back. Studies have not specifically mentioned any safety issues with this method. Since SAVE is neither a drug nor an invasive procedure, it typically poses fewer safety risks compared to other treatments.

The trial is marked as "Not Applicable" for its phase, indicating that complete safety data might not yet be available. However, because it relies solely on ultrasound imaging—a common and safe medical technique—the risks are likely low. Ultrasound is widely used in healthcare and is generally well-tolerated by patients.

In summary, while specific safety data for the SAVE method is not available, its reliance on ultrasound suggests it should be safe. Always consult a doctor if there are concerns or questions about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sub-Hertz Analysis of Viscoelasticity (SAVE) Method for lymphedema because it offers a non-invasive way to analyze tissue properties using ultrasound. Unlike traditional treatments that focus on reducing swelling or discomfort through physical therapy or compression garments, this method aims to gather detailed information about tissue elasticity and viscoelasticity in both affected and unaffected limbs. By understanding these parameters better, it could lead to more precise and personalized treatment strategies in the future, potentially improving outcomes for those with lymphedema.

What evidence suggests that the SAVE method is effective for monitoring lymphedema?

Research has shown that the Sub-Hertz Analysis of Viscoelasticity (SAVE) method uses ultrasound to observe how body tissues stretch and bounce back. This trial will compare two groups: one with lymphedema-affected extremities and another with unaffected extremities as a control. The SAVE method assesses the stiffness or elasticity of swollen tissues, aiding in tracking changes over time. Early results suggest this method effectively detects small differences in tissue, which is crucial for understanding the severity of lymphedema. By providing detailed information about tissue behavior, SAVE could enhance the understanding and management of this condition. ^{1 2 3 4 6}

Who Is on the Research Team?

Antonio Forte, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/record/NCT04258319?term=%22Principal+Investigator%22+OR+%22Investigator%22+AND+%22Germaine+Cuff%22

Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With ... A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

2. withpower.com withpower.com/trial/phase-lymphedema-6-2020-0e222

Ultrasound Analysis for Lymphedema · Info for Participants The SAVE Method is unique because it uses ultrasound to analyze the viscoelastic properties (how tissues stretch and return to shape) of affected tissues, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043422/

Automated In Vivo Sub-Hertz Analysis of Viscoelasticity ... We present an automated method for acquiring images and contrast parameters based on mechanical properties of breast lesions and surrounding tissue

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29989938/

Automated In Vivo Sub-Hertz Analysis of Viscoelasticity (SAVE ... We present an automated method for acquiring images and contrast parameters based on mechanical properties of breast lesions and surrounding tissue at load ...

5. researchgate.net researchgate.net/publication/6388879_Viscoelasticity_imaging_using_ultrasound_Parameters_and_error_analysis

Viscoelasticity imaging using ultrasound: Parameters and error ... The focus of this paper is on imaging parameter estimation from ultrasonic echo data, and how jitter from hand-held force applicators used for clinical ...

6. withpower.com withpower.com/clinical-trials/for-lymphedema-near-long-beach-ca

45 Lymphedema Trials near Long Beach, CA Researchers are trying to validate the use of ultrasound sub-hertz analysis ... Phase 1 trials are the trials to collect safety data in humans. Phase 2 ...