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Sentinel Lymph Node Biopsy for Skin Melanoma

N/A
Waitlist Available
Led By Joseph Skitzki
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This study is evaluating whether intravital microscopy can help identify tumor vessels in patients with melanoma.

Eligible Conditions
  • Skin Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of intravital microscopy in characterizing the microvasculature of the SLN in melanoma determined by successful visualization of at least 6 of 10 patients during Part I
Secondary outcome measures
Flow kinetics associated with the sentinel lymph node vasculature
Survival
Time to progression
+3 more
Other outcome measures
Blood vessel density and diameter assessed from live microscopically-recorded images and from pathology slides

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (intravital microscopy)Experimental Treatment4 Interventions
Patients receive indocyanine green and fluorescein sodium injection IV and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sentinel Lymph Node Biopsy
2004
Completed Phase 3
~330
Diagnostic Microscopy
2017
Completed Early Phase 1
~90
Fluorescein Sodium Injection
2017
Completed Early Phase 1
~90

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,838 Total Patients Enrolled
Joseph SkitzkiPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
17 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy
2016. "Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02857374.
~2 spots leftby Apr 2025
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