NCT02968680

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cutaneous Melanoma
• Melanoma

Interventions

Type	Name	Description
PROCEDURE	Sentinel Lymph Node Biopsy	Undergo SLNB
DEVICE	Ultrasonography	Undergo sonazoid-enhanced ultrasonography
DRUG	Sonazoid	Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.

Timeline

• Start date: 2017-04-26
• Primary completion: 2019-06-28
• Completion: 2020-01-09
• First posted: 2016-11-18
• Last updated: 2020-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study