Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma

Study Overview
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Brief Summary
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This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that may make it easier to see if the tumor cells have spread to the sentinel lymph node using an ultrasound.

Detailed Description
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PRIMARY OBJECTIVES: I. To study the imaging feasibility of peri-tumoral administration of sonazoid ultrasound contrast agent for assessment of sentinel lymph node (SLN) detection in melanoma. II. To compare SLN detection between sonazoid ultrasound and standard of care (SOC) technique. SECONDARY OBJECTIVES: I. To assess the sonazoid ultrasound (US) imaging appearance of lymph nodes which are shown to be involved with metastatic disease. OUTLINE: Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging. Patients also undergo standard of care sentinel lymph node biopsy (SLNB). After completion of study treatment, patients are followed up at 24 and 48 hours.

Official Title
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Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma

Conditions
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Cutaneous Melanoma, Melanoma

Intervention / Treatment
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* Procedure: Sentinel Lymph Node Biopsy
* Device: Ultrasonography
* Drug: Sonazoid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cutaneous melanoma with Breslow depth > 1 mm or melanoma Breslow depth of 0.76 - 1.00 mm in setting of ulceration, extensive regression Mitotic rate >= 1/mm^2 Presence of angiolymphatic invasion Deep positive margin No known allergies to contrast material Exclusion Criteria: Pregnant or nursing Patients with known cardiac shunt Patients with class II heart failure or worse, per New York Heart Association (NYHA) classification Patients who have experienced an acute coronary syndrome or angina in the past 6 months Patients who have undergone coronary artery bypass grafting (CABG) or coronary stenting in the past 3 years Patients with evidence of moderate or severe cardiac valvular disease on echocardiogram Patients with evidence of moderate or severe pulmonary hypertension on echocardiogram Patients with stage II chronic obstructive pulmonary disease (COPD) or worse, per Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification Patients with hypersensitivity to sonazoid or one of its components Patients with hypersensitivity to egg or egg products, because sonazoid contains a chicken egg-derived surfactant (hydrogenated egg phosphatidylserine sodium) Patients who cannot consent for themselves

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (sonazoid, ultrasound imaging, SLNB)<br>Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB. | Procedure: Sentinel Lymph Node Biopsy<br>* Undergo SLNB<br>* Other names: SNB;Device: Ultrasonography<br>* Undergo sonazoid-enhanced ultrasonography<br>* Other names: US;Drug: Sonazoid<br>* Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.<br>* Other names: Contrast ultrasound microvascular perfusion imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods | Analyzed using descriptive comparison. | Up to 1 year |