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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05613946
Other study ID # 22-006006
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date December 15, 2022
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Part 1 - Evaluate the uptake of microbubble agent (Lumason®, Optison®, and Definity®) for lymphatic visualization by ultrasound. Part 2 - Combine preoperative high-frequency B-mode ultrasound with contrast-enhanced ultrasound to identify patent lymphatic channels for lymphaticovenous anastomosis presurgical planning. Evaluate the utility of ultrasound shear wave elastography for assessing treatment response at 6-month follow up.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 26
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lumason
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
Optison
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
Definity
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lymphatic vessel visualization The time from injection to lymphatic visualization, the duration of contrast visualization, and the longest length of lymphatic channel visualized for each injection site will be determined 5 minutes after injection
Primary High-frequency ultrasound and shear-wave elastography Identify any patent lymphatic channels on CEUS or high-frequency ultrasound that were not detected by the reference standard ICG lymphography. We will additionally measure dermal thickness on B-mode ultrasound and perform SWE at levels comparable to the lymphedema grading metrics routinely collected at surgical visits. 1.5 hours for intraoperative CEUS and out-patient SWE both at baseline and 6-month follow-up
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