Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma
March 26, 2020 updated by: University of Southern California
Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic (sonazoid, ultrasound imaging, SLNB)
Patients receive sonazoid ID and undergo ultrasound imaging.
Patients also undergo standard of care SLNB.
|
Undergo SLNB
Other Names:
Undergo sonazoid-enhanced ultrasonography
Other Names:
Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods
Time Frame: Up to 1 year
|
Analyzed using descriptive comparison.
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kevin King, MD, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 26, 2017
Primary Completion (Actual)
June 28, 2019
Study Completion (Actual)
January 9, 2020
Study Registration Dates
First Submitted
August 2, 2016
First Submitted That Met QC Criteria
November 16, 2016
First Posted (Estimate)
November 18, 2016
Study Record Updates
Last Update Posted (Actual)
March 30, 2020
Last Update Submitted That Met QC Criteria
March 26, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10M-15-3 (Other Identifier: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2016-01088 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.