A Pilot Study of Feasibility of Performing Intravital Microscopy in Melanoma Patients
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 as a marker of tumor vessel permeability. (Part II)
OUTLINE:
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Feasibility of performing intravital microscopy on accessible human melanoma tumors during standard local excision
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.
Up to 2 months
No
Joseph Skitzki
Principal Investigator
Roswell Park Cancer Institute
United States: Institutional Review Board
I 231512
NCT01886235
June 2013
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |