Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema
- Conditions
- Lymphedema Arm
- Registration Number
- NCT05613946
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 10
Inclusion Criteria:<br><br> - Unilateral lymphedema in the upper extremity (ISL stage 2 or 3) secondary to breast<br> cancer or breast cancer treatment.<br><br> - Patient qualifies for LVA surgery as determined by the plastic surgeons performing<br> the surgery (Dr. Bill Tran or Dr. Vahe Fahradyan), and the patient consents to<br> surgery.<br><br> - Patient must be able to come to the 6-month clinical follow-up appointment (Part 2<br> only).<br><br> - Patients must be able to understand the study procedures and comply with them for<br> the entire length of the study.<br><br> - No contraception is necessary or required.<br><br>Exclusion Criteria:<br><br> - Pregnant or nursing women.<br><br> - Known or suspected hypersensitivity to microbubble contrast agent, perflutren, blood<br> products, albumin, polyethylene glycol (PEG), or egg.31.<br><br> - Known or suspected cardiac shunts.<br><br> - Prior lymphedema surgery in the upper extremity.<br><br> - Tattoo or scar on either upper extremity.<br><br> - Current drug or alcohol use or dependence that, in the opinion of the investigator,<br> would interfere with adherence to study requirements.<br><br> - Inability or unwillingness of individual or legal guardian/representative to give<br> written informed consent..<br><br> - Current or past participation within a specified timeframe in another clinical<br> trial, as warranted by the administration of this intervention.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lymphatic vessel visualization;High-frequency ultrasound and shear-wave elastography
- Secondary Outcome Measures
Name Time Method