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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02968680

Enrollment

Registered

2016-11-18

Start date

2017-04-26

Completion date

2020-01-09

Last updated

2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Melanoma, Melanoma

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.

Interventions

PROCEDURESentinel Lymph Node Biopsy

Undergo SLNB

DEVICEUltrasonography

Undergo sonazoid-enhanced ultrasonography

DRUGSonazoid

Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026