Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy
- Conditions
- Stage IIC Skin MelanomaStage IIIA Skin MelanomaStage IIB Skin MelanomaStage IIIB Skin MelanomaStage IB Skin MelanomaStage IIIC Skin MelanomaStage IIA Skin Melanoma
- Interventions
- Procedure: Diagnostic MicroscopyOther: Laboratory Biomarker AnalysisProcedure: Sentinel Lymph Node Biopsy
- Registration Number
- NCT02857374
- Lead Sponsor
- Roswell Park Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (intravital microscopy) Sentinel Lymph Node Biopsy 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. Diagnostic (intravital microscopy) Diagnostic Microscopy 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. Diagnostic (intravital microscopy) Fluorescein Sodium Injection 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. Diagnostic (intravital microscopy) Laboratory Biomarker Analysis 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.
- Primary Outcome Measures
Name Time Method 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 Up to 3 weeks 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
Name Time Method Treatment response Up to 5 years Assessed using Logistic Regression. Collected through routine follow-up processes.
Flow kinetics associated with the sentinel lymph node vasculature Up to 5 years Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.
Utility of using commonly used fluorescent agents during human intravital microscopy Up to 3 weeks Vascular blood flow parameters associated with the sentinel lymph node vasculature Up to 5 years Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.
Survival Up to 5 years Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Time to progression Up to 5 years Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States