CASTLE: Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Microbubble contrast agent Lumason 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
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
Other Names:
|
| Other: Microbubble contrast agent Optison 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
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
Other Names:
|
| Other: Microbubble contrast agent Definity 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
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Lymphatic vessel visualization [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
- High-frequency ultrasound and shear-wave elastography [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Unilateral lymphedema in the upper extremity (ISL stage 2 or 3) secondary to breast cancer or breast cancer treatment.
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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.
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Patient must be able to come to the 6-month clinical follow-up appointment (Part 2 only).
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Patients must be able to understand the study procedures and comply with them for the entire length of the study.
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No contraception is necessary or required.
Exclusion Criteria:
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Pregnant or nursing women.
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Known or suspected hypersensitivity to microbubble contrast agent, perflutren, blood products, albumin, polyethylene glycol (PEG), or egg.31.
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Known or suspected cardiac shunts.
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Prior lymphedema surgery in the upper extremity.
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Tattoo or scar on either upper extremity.
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Current drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
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Inability or unwillingness of individual or legal guardian/representative to give written informed consent..
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Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Christine Lee, MD, PhD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 22-006006