This pilot clinical trial studies intravital microscopy for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma.
PRIMARY OBJECTIVES: I. To determine the feasibility of performing intravital microscopy on accessible human melanoma tumors during their standard course of treatment (i.e., wide local excision). (Part I) SECONDARY OBJECTIVES: I. To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein (fluorescein sodium) as a marker of tumor vessel permeability. (Part II) OUTLINE: Patients receive fluorescein sodium intravenously (IV) followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma. After completion of study treatment, patients are followed up at 3 weeks and then periodically for 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
Undergo intravital microscopy
Given IV
Correlative studies
Undergo surgery
Roswell Park Cancer Institute
Buffalo, New York, United States
Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision
A successful intravital microscopic observation will include the ability to identify tumor vessels, measure tumor vessel diameters, determine vessel density per 10 x field and visualize fluorescein within the tumor vessels.
Time frame: Up to 2 months
"Percentage of Participants With Any Adverse Event
Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits.
Time frame: Up to 5 years
Blood Flow Rates
Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.
Time frame: Up to 2 months
Complication Rate
Number of participants with an event that would disrupt the standard surgical procedure or create an adverse event that would not be anticipated from the standard surgery.
Time frame: Up to 5 years
Median Overall Survival
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time frame: Up to 5 years
Median Progression Free Survival
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time frame: Up to 5 years
Percentage of Participants With Treatment Response
Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites.
Time frame: Up to 5 years
Tumor Vasculature
Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.
Time frame: Up to 2 months
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