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

NCT02857374 | Completed DMC

• 2 other identifiers: I 284116NCI-2016-01076
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Flow kinetics associated with the sentinel lymph node vasculature

  Up to 5 years

• Survival

  Up to 5 years

• Time to progression

  Up to 5 years

• Treatment response

  Up to 5 years

• Utility of using commonly used fluorescent agents during human intravital microscopy

  Up to 3 weeks

Other Outcomes (1)

• Blood vessel density and diameter assessed from live microscopically-recorded images and from pathology slides

  Up to 5 years

Study Arms (1)

Diagnostic (intravital microscopy)

EXPERIMENTAL

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.

Procedure: Diagnostic Microscopy; Drug: Fluorescein Sodium Injection; Other: Laboratory Biomarker Analysis; Procedure: Sentinel Lymph Node Biopsy

Interventions

Diagnostic Microscopy PROCEDURE

Undergo intravital microscopy

Diagnostic (intravital microscopy)

Fluorescein Sodium Injection DRUG

Given IV

Also known as: AK-Fluor, Fluorescite

Diagnostic (intravital microscopy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (intravital microscopy)

Sentinel Lymph Node Biopsy PROCEDURE

Undergo standard of care sentinel node biopsy

Also known as: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

Diagnostic (intravital microscopy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Fluorescein; Fluoresceins; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Joseph Skitzki

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 5, 2016
• Study Start: November 3, 2016
• Primary Completion: August 28, 2018
• Study Completion: June 13, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

US (1)