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

Lymphedema Arm Clinical Trial

— CASTLE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

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

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• 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: 24
• 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.

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema Arm

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

External Links

•   Lymphatic Mapping with Contrast-Enhanced Ultrasound (manuscript)