Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema (CASTLE)
Lymphedema Arm
About this trial
This is an interventional diagnostic trial for Lymphedema Arm focused on measuring Lymphaticovenous anastomosis surgery
Eligibility Criteria
Inclusion Criteria: Unilateral lymphedema in the upper extremity (ISL stage 2 or 3) secondary to breast cancer or breast cancer treatment. Patient qualifies for LVA surgery as determined by the plastic surgeons performing the surgery (Dr. Bill Tran or Dr. Vahe Fahradyan), and the patient consents to surgery. Patient must be able to come to the 6-month clinical follow-up appointment (Part 2 only). Patients must be able to understand the study procedures and comply with them for the entire length of the study. No contraception is necessary or required. Exclusion Criteria: Pregnant or nursing women. Known or suspected hypersensitivity to microbubble contrast agent, perflutren, blood products, albumin, polyethylene glycol (PEG), or egg.31. Known or suspected cardiac shunts. Prior lymphedema surgery in the upper extremity. Tattoo or scar on either upper extremity. Current drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. Inability or unwillingness of individual or legal guardian/representative to give written informed consent.. Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
Microbubble contrast agent Lumason
Microbubble contrast agent Optison
Microbubble contrast agent Definity
While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.
While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.
While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.