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

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.

Study Overview

• Status: Completed
• Conditions: Stage IV Skin Melanoma; Recurrent Melanoma; 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 IA Skin Melanoma; Stage IB Skin Melanoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Therapeutic Conventional Surgery; Procedure: Diagnostic Microscopy; Drug: Fluorescein Sodium Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• 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
• Have measurable disease in their skin by direct visualization (visible lesion typically > 0.5 cm in maximal diameter); to perform a microscopic observation, the lesion will have to be visible by the naked eye, lined-up visually, and be able to interface with the microscope objective; a melanoma lesion that is smaller than 0.5 cm in diameter would present several obstacles to obtaining a reliable microscopic observation in the operating room; therefore, a visible lesion, at a minimum of 0.5 cm in diameter, is proposed for this study
• Melanoma tumor that requires a wide local excision in the operating room; this may include any stage of melanoma from stage IA to stage IV that requires a wide excision in the operating room
• Subject 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
• To determine any sensitivity to fluorescein, subject must have a skin prick test preoperatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given); a negative skin prick test to fluorescein is an inclusion criteria

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
• Melanoma deposit is deemed inaccessible to microscopic observation during the operative procedure (i.e., lesion is less than 0.5 cm or is not clearly visible to the naked eye)
• Renal dysfunction as defined as a glomerular filtration rate (GFR) < 70
• Any known allergy or prior reaction to fluorescein; also, a positive skin prick test to fluorescein is considered an exclusion criteria and the patient would not be eligible for entry into this study
• Pregnant or nursing female subjects
• Unwilling or unable to follow protocol requirements
• Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiogram [EKG], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnosis (intravital microscopy); Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.	Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Therapeutic Conventional Surgery; Undergo surgery; Procedure: Diagnostic Microscopy; Undergo intravital microscopy; Drug: Fluorescein Sodium Injection; Given IV; Other Names: Fluorescite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision	A successful intravital microscopic observation will include the ability to identify tumor vessels, measure tumor vessel diameters, determine vessel density per 10 x field and visualize fluorescein within the tumor vessels.	Up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"Percentage of Participants With Any Adverse Event	Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits.	Up to 5 years
Blood Flow Rates	Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.	Up to 2 months
Complication Rate	Number of participants with an event that would disrupt the standard surgical procedure or create an adverse event that would not be anticipated from the standard surgery.	Up to 5 years
Median Overall Survival	Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.	Up to 5 years
Median Progression Free Survival	Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.	Up to 5 years
Percentage of Participants With Treatment Response	Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites.	Up to 5 years
Tumor Vasculature	Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.	Up to 2 months

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2013
• Primary Completion (Actual): June 16, 2015
• Study Completion (Actual): May 6, 2020

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

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 231512 (Other Identifier: Roswell Park Cancer Institute); P30CA016056 (U.S. NIH Grant/Contract); NCI-2013-01052 (Registry Identifier: CTRP (Clinical Trial Reporting Program))