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

NCT05613946 | Completed Phase 1 FDA Drug

• 1 other identifier: 22-006006
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema Arm

Keywords

Lymphaticovenous anastomosis surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Microbubble contrast agent Lumason

OTHER

While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.

Drug: Lumason

Microbubble contrast agent Optison

OTHER

While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.

Drug: Optison

Microbubble contrast agent Definity

OTHER

While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.

Drug: Definity

Interventions

Lumason DRUG

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

Also known as: sulfur hexafluoride lipid-type A microspheres

Microbubble contrast agent Lumason

Optison DRUG

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

Also known as: perflutren protein-type A microspheres

Microbubble contrast agent Optison

Definity DRUG

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

Also known as: perflutren lipid microsphere

Microbubble contrast agent Definity

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Lymphatic Mapping with Contrast-Enhanced Ultrasound (manuscript)

MeSH Terms

Interventions

FS 069; perflutren

Study Officials

• Christine Lee, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: December 15, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)