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

Phase 1

Terminated

• Conditions: Cutaneous Melanoma; Melanoma
• Interventions: Procedure: Sentinel Lymph Node Biopsy; Device: Ultrasonography; Drug: Sonazoid

• Registration Number: NCT02968680
• Lead Sponsor: University of Southern California

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Study Start: 2017-04-26
• Primary Completion: 2019-06-28
• Study Completion: 2020-01-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (sonazoid, ultrasound imaging, SLNB)	Sentinel Lymph Node Biopsy	Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.
Diagnostic (sonazoid, ultrasound imaging, SLNB)	Ultrasonography	Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.
Diagnostic (sonazoid, ultrasound imaging, SLNB)	Sonazoid	Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.

Primary Outcome Measures

Name	Time	Method
Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods	Up to 1 year	Analyzed using descriptive comparison.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States