Clinical trial NCT02968680: Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma
Official title: Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cutaneous Melanoma
Melanoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-11-18
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Kevin King, MD
role: PRINCIPAL_INVESTIGATOR
References: