Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy

Intravital Microscopy (IVM) During Sentinel Lymph Node (SLN) Biopsy for Melanoma

This pilot clinical trial studies intravital microscopy in identifying tumor vessels in patients with stage IB-IIIC melanoma undergoing sentinel lymph node biopsy. By examining sentinel lymph nodes through intravital microscopy before they are removed, doctors may learn specific information regarding how melanoma may spread to lymph nodes and other sites of the body.

Study Overview

• Status: Completed
• Conditions: Stage IIIB Skin Melanoma; Stage IIIC Skin Melanoma; Stage IIA Skin Melanoma; Stage IIB Skin Melanoma; Stage IIC Skin Melanoma; Stage IIIA Skin Melanoma; Stage IB Skin Melanoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Diagnostic Microscopy; Drug: Fluorescein Sodium Injection; Procedure: Sentinel Lymph Node Biopsy

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the feasibility of intravital microscopy in characterizing the microvasculature of the sentinel lymph node (SLN) in melanoma patients requiring SLN biopsy.

SECONDARY OBJECTIVES:

I. To identify vascular blood flow parameters and flow kinetics associated with the sentinel lymph node vasculature and define the utility of using commonly used fluorescent agents during human intravital microscopy and correlate with clinical outcomes (time to recurrence, survival), as a potential basis for a novel prognostic tool and/or microstaging technique.

TERTIARY OBJECTIVES:

I. To determine the relationship between live microscopically-recorded images and pathology slides in terms of vessel density and vessel diameter.

OUTLINE:

Patients receive indocyanine green and fluorescein sodium injection intravenously (IV) and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy.

After completion of study treatment, patients are followed up at 3 weeks and then every 6 months for 5 years or every 3 months for 2 years and every 6 months for another 2 years.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
• Melanoma tumor that meets indications for a groin SLN biopsy with a >= 10% risk of having metastasis to the draining lymph node (i.e. stage IB to stage IIIC melanoma of the lower body below the umbilicus)
• Participant must be eligible for a groin sentinel lymph node (SLN) biopsy
• Participant 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

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
• Sentinel lymph node is deemed inaccessible to microscopic observation during the operative procedure (i.e. sentinel node maps to a deep location or area outside of the groin)
• Renal dysfunction as defined as creatinine clearance < 70 mL/min by Cockroft-Gault equation
• Any known allergy or prior reaction to fluorescein, indocyanine green, iodine, or shellfish
• Unwilling or unable to follow protocol requirements
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiogram [EKG], chest x-ray, or pulmonary function tests)
• Any condition that excludes SLN biopsy as the standard of care (e.g. lymphadenectomy indicated)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Diagnostic (intravital microscopy); 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Diagnostic Microscopy; Undergo intravital microscopy; Drug: Fluorescein Sodium Injection; Given IV; Other Names: AK-Fluor; Fluorescite; Procedure: Sentinel Lymph Node Biopsy; Undergo standard of care sentinel node biopsy; Other Names: Sentinel Node Biopsy; Sentinel node biopsy alone; SLNB; SNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The visualization method will be deemed successful in patients with tumor vessel identification, measurement of tumor vessel diameters, determining vessel density, and visualizing fluorescein/indocyanine green within the tumor vessels.	Up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow kinetics associated with the sentinel lymph node vasculature	Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.	Up to 5 years
Survival	Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.	Up to 5 years
Time to progression	Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.	Up to 5 years
Treatment response	Assessed using Logistic Regression. Collected through routine follow-up processes.	Up to 5 years
Utility of using commonly used fluorescent agents during human intravital microscopy		Up to 3 weeks
Vascular blood flow parameters associated with the sentinel lymph node vasculature	Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.	Up to 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood vessel density and diameter assessed from live microscopically-recorded images and from pathology slides	The relationship between the live microscopically-recorded images and the pathology slides in terms of vessel density and vessel diameter will be determined. Correlations between microscopic observations (vessel diameter, density, blood flow velocity, vessel hierarchy tissue penetration of fluorescein/indocyanine green) with pathologic node positivity and clinical outcomes (time to recurrence, survival) will be analyzed.	Up to 5 years

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 3, 2016
• Primary Completion (ACTUAL): August 28, 2018
• Study Completion (ACTUAL): June 13, 2022

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (ESTIMATE): August 5, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Skin Neoplasms
• Other Study ID Numbers: I 284116 (OTHER: Roswell Park Cancer Institute); NCI-2016-01076 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No