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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01886235
Other study ID # I 231512
Secondary ID NCI-2013-01052I
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2013
Est. completion date May 6, 2020

Study information

Verified date July 2020
Source Roswell Park Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 6, 2020
Est. primary completion date June 16, 2015
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

- 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 Design


Intervention

Procedure:
Diagnostic Microscopy
Undergo intravital microscopy
Drug:
Fluorescein Sodium Injection
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies
Procedure:
Therapeutic Conventional Surgery
Undergo surgery

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Roswell Park Cancer Institute National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 "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
Secondary 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
Secondary 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
Secondary Median Overall Survival Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes. Up to 5 years
Secondary Median Progression Free Survival Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes. Up to 5 years
Secondary 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
Secondary 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
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