Lymphedema Arm
Conditions
Keywords
Lymphaticovenous anastomosis surgery
Brief summary
The purpose of this research is to determine the preferred microbubble agent (Lumason®, Optison®, and Definity®) for lymphatic channel visualization by ultrasound. This research will also evaluate the utility of preoperative high-frequency B-mode ultrasound with contrast-enhanced ultrasound for presurgical planning, and ultrasound shear wave elastography for assessing treatment response at 6-month follow up.
Detailed description
Part 1 - Evaluate the uptake of microbubble agent (Lumason®, Optison®, and Definity®) for lymphatic visualization by ultrasound. Part 2 - Combine preoperative high-frequency B-mode ultrasound with contrast-enhanced ultrasound to identify patent lymphatic channels for lymphaticovenous anastomosis presurgical planning. Evaluate the utility of ultrasound shear wave elastography for assessing treatment response at 6-month follow up.
Interventions
DRUGLumason
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
DRUGOptison
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
DRUGDefinity
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymphatic vessel visualization | 5 minutes after injection | The time from injection to lymphatic visualization, the duration of contrast visualization, and the longest length of lymphatic channel visualized for each injection site will be determined |
| High-frequency ultrasound and shear-wave elastography | 1.5 hours for intraoperative CEUS and out-patient SWE both at baseline and 6-month follow-up | Identify any patent lymphatic channels on CEUS or high-frequency ultrasound that were not detected by the reference standard ICG lymphography. We will additionally measure dermal thickness on B-mode ultrasound and perform SWE at levels comparable to the lymphedema grading metrics routinely collected at surgical visits. |
Countries
United States
Outcome results
None listed