Intravital Microscopy (IVM) During Sentinel Lymph Node (SLN) Biopsy for Melanoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Diagnostic (intravital 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.
Intervention: Diagnostic Microscopy (Procedure)
Diagnostic (intravital 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.
Intervention: Fluorescein Sodium Injection (Drug)
Diagnostic (intravital 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.
Intervention: Laboratory Biomarker Analysis (Other)
Diagnostic (intravital 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.
Intervention: Sentinel Lymph Node Biopsy (Procedure)
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- Treatment response(Up to 5 years)
- Flow kinetics associated with the sentinel lymph node vasculature(Up to 5 years)
- 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)
- Survival(Up to 5 years)
- Time to progression(Up to 5 years)