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Completed

NCT Number: NCT05613946

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

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.

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Key information

Conditions

Lymphedema Arm

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lumason

Drug

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

Other names: sulfur hexafluoride lipid-type A microspheres

Optison

Drug

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

Other names: perflutren protein-type A microspheres

Definity

Drug

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

Other names: perflutren lipid microsphere

Primary outcomes

  1. Lymphatic vessel visualization

    Time frame: 5 minutes after injection

    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

  2. High-frequency ultrasound and shear-wave elastography

    Time frame: 1.5 hours for intraoperative CEUS and out-patient SWE both at baseline and 6-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Contrast-enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema (CASTLE) Study

Acronym: CASTLE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2022
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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