Study 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.
Eligible Conditions
- Lymphedema Arm
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: 1.5 hours for intraoperative CEUS and out-patient SWE both at baseline and 6-month follow-up
Hour 5
High-frequency ultrasound and shear-wave elastography
5 minutes after injection
Lymphatic vessel visualization
Trial Safety
Trial Design
0 Treatment Group
24 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1.5 hours for intraoperative ceus and out-patient swe both at baseline and 6-month follow-up
Who is running the clinical trial?
Mayo ClinicLead Sponsor
2,917 Previous Clinical Trials
3,507,127 Total Patients Enrolled
Christine Lee, MD, PhDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
8 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Female Participants · 5 Total Inclusion Criteria
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Conditions
Cancer Related
Treatments