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

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

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.

Study Overview

• Status: Terminated
• Conditions: Melanoma; Cutaneous Melanoma
• Intervention / Treatment: Procedure: Sentinel Lymph Node Biopsy; Device: Ultrasonography; Drug: Sonazoid

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (sonazoid, ultrasound imaging, SLNB); Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.

Procedure: Sentinel Lymph Node Biopsy; Undergo SLNB; Other Names: Sentinel Node Biopsy; Sentinel node biopsy alone; SLNB; SNB; Device: Ultrasonography; Undergo sonazoid-enhanced ultrasonography; Other Names: Ultrasound Imaging; Ultrasound Test; Ultrasound, Medical; US; ULTRASOUND; Drug: Sonazoid; Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.; Other Names: Contrast ultrasound microvascular perfusion imaging

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kevin King, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2017
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): January 9, 2020

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Skin Neoplasms
• Other Study ID Numbers: 10M-15-3 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2016-01088 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No