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A Pilot Study of Feasibility of Performing Intravital Microscopy in Melanoma Patients

18 Years
Not Enrolling
Recurrent Melanoma, Stage IA Melanoma, Stage IB Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma

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Trial Information

A Pilot Study of Feasibility of Performing Intravital Microscopy in Melanoma Patients


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. To determine the blood flow velocity of the tumor vessels and tissue penetration of
fluorescein as a marker of tumor vessel permeability. (Part II)


Patients receive fluorescein 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 periodically for 6-10 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)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility of performing intravital microscopy on accessible human melanoma tumors during standard local excision

Outcome Description:

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.

Outcome Time Frame:

Up to 2 months

Safety Issue:


Principal Investigator

Joseph Skitzki

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Institutional Review Board

Study ID:

I 231512



Start Date:

June 2013

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IA Melanoma
  • Stage IB Melanoma
  • Stage IIA Melanoma
  • Stage IIB Melanoma
  • Stage IIC Melanoma
  • Stage IIIA Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma
  • Melanoma



Roswell Park Cancer Institute Buffalo, New York  14263