This phase I trial evaluates contrast-enhanced ultrasound (CEUS) and shear wave elastography (SWE) in planning and assessing lymphedema treatment in breast cancer patients undergoing lymphaticovenous anastomosis (LVA) surgery (lymphovenous bypass). Lymphedema, swelling from an excess of fluid collection in tissue, can occur after surgery or treatment for breast cancer. LVA surgery is a possible treatment to improve lymphedema. CEUS uses high frequency sound waves to generate images of the body following the administration of a microbubble contrast agent (Lumason [registered trademark], Optison [registered trademark], or Definity [registered trademark]) and may allow surgeons to see where lymphatic channels are connected to a vein for more effective lymphatic drainage. This trial also uses SWE, which measures arm stiffness, to evaluate the effect of LVA surgery. Using CEUS and SWE may help improve outcomes for breast cancer patients undergoing LVA surgery for lymphedema treatment.
Additional locations may be listed on ClinicalTrials.gov for NCT05613946.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine if there is a preferred microbubble agent for CEUS lymphatic mapping based on data for lymphatic visualization in a normal upper extremity. (PART 1)
SECONDARY OBJECTIVE:
I. To collect performance data of CEUS and high-frequency ultrasound for preoperative lymphatic mapping. (PART 2)
II. Collect data from ultrasound shear wave elastography (SWE) for prospectively grading upper extremity lymphedema. (PART 2)
II. Collect trimmed lymphatic tissue and characterize the pathological features. (PART 2)
OUTLINE:
PART 1: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive sulfur hexafluoride lipid microspheres (Lumason) intradermally on the healthy arm and undergo CEUS imaging over 30 minutes during scheduled preoperative lymphatic mapping for LVA surgery.
ARM II: Patients receive perflutren protein-type A microspheres (Optison) intradermally on the healthy arm and undergo CEUS imaging over 30 minutes during scheduled preoperative lymphatic mapping for LVA surgery.
ARM III: Patients receive perflutren lipid microspheres (Definity) intradermally on the healthy arm and undergo CEUS imaging over 30 minutes during scheduled preoperative lymphatic mapping for LVA surgery.
PART 2: Patients receive Lumason intradermally on the arm with lymphedema and undergo CEUS lymphatic mapping and brightness (B)-mode US on the day of LVA surgery. Patients also undergo US SWE and additional B-mode US prior to and at 6 months after completion of LVA surgery.
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorChristine U. Lee
