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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-26

Study Completion Date

2020-01-09

Brief Summary

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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.

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Detailed Description

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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

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Cutaneous Melanoma Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (sonazoid, ultrasound imaging, SLNB)

Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.

Group Type EXPERIMENTAL

Sentinel Lymph Node Biopsy

Intervention Type PROCEDURE

Undergo SLNB

Ultrasonography

Intervention Type DEVICE

Undergo sonazoid-enhanced ultrasonography

Sonazoid

Intervention Type DRUG

Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.

Interventions

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Sentinel Lymph Node Biopsy

Undergo SLNB

Intervention Type PROCEDURE

Ultrasonography

Undergo sonazoid-enhanced ultrasonography

Intervention Type DEVICE

Sonazoid

Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.

Intervention Type DRUG

Other Intervention Names

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Sentinel Node Biopsy Sentinel node biopsy alone SLNB SNB ULTRASOUND Ultrasound Imaging Ultrasound Test Ultrasound, Medical US Contrast ultrasound microvascular perfusion imaging

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No