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

University of Southern California

Status and phase

Terminated

Phase 1

Conditions

Melanoma

Cutaneous Melanoma

Treatments

Procedure: Sentinel Lymph Node Biopsy

Device: Ultrasonography

Drug: Sonazoid

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02968680

P30CA014089 (U.S. NIH Grant/Contract)

NCI-2016-01088 (Registry Identifier)

10M-15-3 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

19+ years old

Volunteers

No 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