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

Primary Purpose

Cutaneous Melanoma, Melanoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sentinel Lymph Node Biopsy
Ultrasonography
Sonazoid
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cutaneous Melanoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (sonazoid, ultrasound imaging, SLNB)

Arm Description

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

Outcomes

Primary Outcome Measures

Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods
Analyzed using descriptive comparison.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2016
Last Updated
March 26, 2020
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02968680
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Insufficient accrual
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
January 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Melanoma, Melanoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (sonazoid, ultrasound imaging, SLNB)
Arm Type
Experimental
Arm Description
Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.
Intervention Type
Procedure
Intervention Name(s)
Sentinel Lymph Node Biopsy
Other Intervention Name(s)
Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Intervention Description
Undergo SLNB
Intervention Type
Device
Intervention Name(s)
Ultrasonography
Other Intervention Name(s)
ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical, US
Intervention Description
Undergo sonazoid-enhanced ultrasonography
Intervention Type
Drug
Intervention Name(s)
Sonazoid
Other Intervention Name(s)
Contrast ultrasound microvascular perfusion imaging
Intervention Description
Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.
Primary Outcome Measure Information:
Title
Percent of patients with SLN identified by sonazoid-US alone or both sonazoid-US and conventional methods
Description
Analyzed using descriptive comparison.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin King, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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