search
Back to results

Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy

Primary Purpose

Stage IB Skin Melanoma, Stage IIA Skin Melanoma, Stage IIB Skin Melanoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic Microscopy
Fluorescein Sodium Injection
Laboratory Biomarker Analysis
Sentinel Lymph Node Biopsy
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stage IB Skin Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Melanoma tumor that meets indications for a groin SLN biopsy with a >= 10% risk of having metastasis to the draining lymph node (i.e. stage IB to stage IIIC melanoma of the lower body below the umbilicus)
  • Participant must be eligible for a groin sentinel lymph node (SLN) biopsy
  • Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Sentinel lymph node is deemed inaccessible to microscopic observation during the operative procedure (i.e. sentinel node maps to a deep location or area outside of the groin)
  • Renal dysfunction as defined as creatinine clearance < 70 mL/min by Cockroft-Gault equation
  • Any known allergy or prior reaction to fluorescein, indocyanine green, iodine, or shellfish
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiogram [EKG], chest x-ray, or pulmonary function tests)
  • Any condition that excludes SLN biopsy as the standard of care (e.g. lymphadenectomy indicated)

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (intravital microscopy)

Arm Description

Patients receive indocyanine green and fluorescein sodium injection IV and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy.

Outcomes

Primary Outcome Measures

Feasibility of intravital microscopy in characterizing the microvasculature of the SLN in melanoma determined by successful visualization of at least 6 of 10 patients during Part I
The visualization method will be deemed successful in patients with tumor vessel identification, measurement of tumor vessel diameters, determining vessel density, and visualizing fluorescein/indocyanine green within the tumor vessels.

Secondary Outcome Measures

Flow kinetics associated with the sentinel lymph node vasculature
Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.
Survival
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time to progression
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Treatment response
Assessed using Logistic Regression. Collected through routine follow-up processes.
Utility of using commonly used fluorescent agents during human intravital microscopy
Vascular blood flow parameters associated with the sentinel lymph node vasculature
Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.

Full Information

First Posted
July 29, 2016
Last Updated
July 28, 2022
Sponsor
Roswell Park Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02857374
Brief Title
Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy
Official Title
Intravital Microscopy (IVM) During Sentinel Lymph Node (SLN) Biopsy for Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 3, 2016 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
June 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

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

5. Study Description

Brief Summary
This pilot clinical trial studies intravital microscopy in identifying tumor vessels in patients with stage IB-IIIC melanoma undergoing sentinel lymph node biopsy. By examining sentinel lymph nodes through intravital microscopy before they are removed, doctors may learn specific information regarding how melanoma may spread to lymph nodes and other sites of the body.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the feasibility of intravital microscopy in characterizing the microvasculature of the sentinel lymph node (SLN) in melanoma patients requiring SLN biopsy. SECONDARY OBJECTIVES: I. To identify vascular blood flow parameters and flow kinetics associated with the sentinel lymph node vasculature and define the utility of using commonly used fluorescent agents during human intravital microscopy and correlate with clinical outcomes (time to recurrence, survival), as a potential basis for a novel prognostic tool and/or microstaging technique. TERTIARY OBJECTIVES: I. To determine the relationship between live microscopically-recorded images and pathology slides in terms of vessel density and vessel diameter. OUTLINE: Patients receive indocyanine green and fluorescein sodium injection intravenously (IV) and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy. After completion of study treatment, patients are followed up at 3 weeks and then every 6 months for 5 years or every 3 months for 2 years and every 6 months for another 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IB Skin Melanoma, Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (intravital microscopy)
Arm Type
Experimental
Arm Description
Patients receive indocyanine green and fluorescein sodium injection IV and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy.
Intervention Type
Procedure
Intervention Name(s)
Diagnostic Microscopy
Intervention Description
Undergo intravital microscopy
Intervention Type
Drug
Intervention Name(s)
Fluorescein Sodium Injection
Other Intervention Name(s)
AK-Fluor, Fluorescite
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
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 standard of care sentinel node biopsy
Primary Outcome Measure Information:
Title
Feasibility of intravital microscopy in characterizing the microvasculature of the SLN in melanoma determined by successful visualization of at least 6 of 10 patients during Part I
Description
The visualization method will be deemed successful in patients with tumor vessel identification, measurement of tumor vessel diameters, determining vessel density, and visualizing fluorescein/indocyanine green within the tumor vessels.
Time Frame
Up to 3 weeks
Secondary Outcome Measure Information:
Title
Flow kinetics associated with the sentinel lymph node vasculature
Description
Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.
Time Frame
Up to 5 years
Title
Survival
Description
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time Frame
Up to 5 years
Title
Time to progression
Description
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time Frame
Up to 5 years
Title
Treatment response
Description
Assessed using Logistic Regression. Collected through routine follow-up processes.
Time Frame
Up to 5 years
Title
Utility of using commonly used fluorescent agents during human intravital microscopy
Time Frame
Up to 3 weeks
Title
Vascular blood flow parameters associated with the sentinel lymph node vasculature
Description
Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.
Time Frame
Up to 5 years
Other Pre-specified Outcome Measures:
Title
Blood vessel density and diameter assessed from live microscopically-recorded images and from pathology slides
Description
The relationship between the live microscopically-recorded images and the pathology slides in terms of vessel density and vessel diameter will be determined. Correlations between microscopic observations (vessel diameter, density, blood flow velocity, vessel hierarchy tissue penetration of fluorescein/indocyanine green) with pathologic node positivity and clinical outcomes (time to recurrence, survival) will be analyzed.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 Melanoma tumor that meets indications for a groin SLN biopsy with a >= 10% risk of having metastasis to the draining lymph node (i.e. stage IB to stage IIIC melanoma of the lower body below the umbilicus) Participant must be eligible for a groin sentinel lymph node (SLN) biopsy Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Sentinel lymph node is deemed inaccessible to microscopic observation during the operative procedure (i.e. sentinel node maps to a deep location or area outside of the groin) Renal dysfunction as defined as creatinine clearance < 70 mL/min by Cockroft-Gault equation Any known allergy or prior reaction to fluorescein, indocyanine green, iodine, or shellfish Unwilling or unable to follow protocol requirements Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiogram [EKG], chest x-ray, or pulmonary function tests) Any condition that excludes SLN biopsy as the standard of care (e.g. lymphadenectomy indicated)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Skitzki
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy

We'll reach out to this number within 24 hrs