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

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.

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)