Melanoma Clinical Trial
Official title:
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.
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.
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