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Recruiting NCT05613946

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

Conditions: Lymphedema Arm

Sex: Female
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 24
Sponsor: Mayo Clinic

Location: United States

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.

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05613946). StuddyBuddy aggregates publicly available trial information.