Clinical Trials Directory

Trials / Completed

CompletedNCT01886235

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Roswell Park Cancer Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This pilot clinical trial studies intravital microscopy for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREDiagnostic MicroscopyUndergo intravital microscopy
DRUGFluorescein Sodium InjectionGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
PROCEDURETherapeutic Conventional SurgeryUndergo surgery

Timeline

Start date
2013-09-04
Primary completion
2015-06-16
Completion
2020-05-06
First posted
2013-06-25
Last updated
2020-08-07
Results posted
2017-06-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01886235. Inclusion in this directory is not an endorsement.