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

Stage IIIC Skin Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857374
• Other study ID #: I 284116
• Secondary ID: NCI-2016-01076I
• Status: Completed
• Phase: N/A
• Start date: November 3, 2016
• Est. completion date: June 13, 2022

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 13, 2022
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Melanoma
• Skin Neoplasms
• Stage IB Skin Melanoma
• Stage IIA Skin Melanoma
• Stage IIB Skin Melanoma
• Stage IIC Skin Melanoma
• Stage IIIA Skin Melanoma
• Stage IIIB Skin Melanoma
• Stage IIIC Skin Melanoma

Intervention

Procedure:
• Diagnostic Microscopy
Undergo intravital microscopy

Drug:
• Fluorescein Sodium Injection
Given IV

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Sentinel Lymph Node Biopsy
Undergo standard of care sentinel node biopsy

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	Survival	Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.	Up to 5 years
Secondary	Time to progression	Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.	Up to 5 years
Secondary	Treatment response	Assessed using Logistic Regression. Collected through routine follow-up processes.	Up to 5 years
Secondary	Utility of using commonly used fluorescent agents during human intravital microscopy		Up to 3 weeks
Secondary	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