Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema

• Status: Not yet recruiting
• Trial end date: 2024-03-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

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.