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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Undergo intravital microscopy
Given IV
Correlative studies
Undergo standard of care sentinel node biopsy
Roswell Park Cancer Institute
Buffalo, New York, United States
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.
Time frame: Up to 3 weeks
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.
Time frame: Up to 5 years
Survival
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time frame: Up to 5 years
Time to progression
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time frame: Up to 5 years
Treatment response
Assessed using Logistic Regression. Collected through routine follow-up processes.
Time frame: Up to 5 years
Utility of using commonly used fluorescent agents during human intravital microscopy
Time frame: Up to 3 weeks
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.
Time frame: Up to 5 years
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