Treatment for Lymphedema Arm

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lymphedema Arm
Eligibility
18+
Female
What conditions do you have?
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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

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

Mark “Yes” if the following statements are true for you:
You must be able to understand the study procedures and comply with them for the entire length of the study.