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

• Status: Terminated
• Trial end date: 2020-01-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)

Criteria

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