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

NCT02968680 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: 10M-15-3NCI-2016-01088P30CA014089
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Melanoma; Melanoma

Outcome Measures

Primary Outcomes (1)

• Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods

  Analyzed using descriptive comparison.

  Up to 1 year

Study Arms (1)

Diagnostic (sonazoid, ultrasound imaging, SLNB)

EXPERIMENTAL

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

Procedure: Sentinel Lymph Node Biopsy; Device: Ultrasonography; Drug: Sonazoid

Interventions

Sentinel Lymph Node Biopsy PROCEDURE

Undergo SLNB

Also known as: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

Diagnostic (sonazoid, ultrasound imaging, SLNB)

Ultrasonography DEVICE

Undergo sonazoid-enhanced ultrasonography

Also known as: ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical, US

Diagnostic (sonazoid, ultrasound imaging, SLNB)

Sonazoid DRUG

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

Also known as: Contrast ultrasound microvascular perfusion imaging

Diagnostic (sonazoid, ultrasound imaging, SLNB)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Sentinel Lymph Node Biopsy; Ultrasonography; Sonazoid

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques; Diagnostic Imaging

Study Officials

• Kevin King, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: November 18, 2016
• Study Start: April 26, 2017
• Primary Completion: June 28, 2019
• Study Completion: January 9, 2020
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

US (1)