Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery

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.

Inclusion Criteria:

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Have measurable disease in their skin by direct visualization (visible lesion
typically > 0.5 cm in maximal diameter); to perform a microscopic observation, the
lesion will have to be visible by the naked eye, lined-up visually, and be able to
interface with the microscope objective; a melanoma lesion that is smaller than 0.5 cm
in diameter would present several obstacles to obtaining a reliable microscopic
observation in the operating room; therefore, a visible lesion, at a minimum of 0.5 cm
in diameter, is proposed for this study

- Melanoma tumor that requires a wide local excision in the operating room; this may
include any stage of melanoma from stage IA to stage IV that requires a wide excision
in the operating room

- Subject 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

- To determine any sensitivity to fluorescein, subject must have a skin prick test
preoperatively (at the time of the preoperative visit and after signed informed
consent for entry into this clinical trial is given); a negative skin prick test to
fluorescein is an inclusion criteria

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

- Melanoma deposit is deemed inaccessible to microscopic observation during the
operative procedure (i.e., lesion is less than 0.5 cm or is not clearly visible to the
naked eye)

- Renal dysfunction as defined as a glomerular filtration rate (GFR) < 70

- Any known allergy or prior reaction to fluorescein; also, a positive skin prick test
to fluorescein is considered an exclusion criteria and the patient would not be
eligible for entry into this study

- Pregnant or nursing female subjects

- Unwilling or unable to follow protocol requirements

- Any condition which in the Investigator's opinion deems the subject an unsuitable
candidate to undergo observational study (may also include preoperative testing
results including electrocardiogram [EKG], chest x-ray, or pulmonary function tests
that preclude a wide excision in the operating room)