Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT01886235|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2013
Results First Posted : June 6, 2017
Last Update Posted : December 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Melanoma Stage IA Skin Melanoma 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 Stage IV Skin Melanoma||Procedure: Diagnostic Microscopy Drug: Fluorescein Sodium Injection Other: Laboratory Biomarker Analysis Procedure: Therapeutic Conventional Surgery||Not Applicable|
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)
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)
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Feasibility of Performing Intravital Microscopy in Melanoma Patients|
|Actual Study Start Date :||September 4, 2013|
|Actual Primary Completion Date :||June 16, 2015|
|Estimated Study Completion Date :||February 16, 2019|
Experimental: Diagnosis (intravital microscopy)
Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Procedure: Diagnostic Microscopy
Undergo intravital microscopy
Drug: Fluorescein Sodium Injection
Other Name: Fluorescite
Other: Laboratory Biomarker Analysis
Procedure: Therapeutic Conventional Surgery
- Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision [ Time Frame: Up to 2 months ]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.
- "Percentage of Participants With Any Adverse Event [ Time Frame: Up to 5 years ]Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits.
- Blood Flow Rates [ Time Frame: Up to 2 months ]Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.
- Complication Rate [ Time Frame: Up to 5 years ]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.
- Median Overall Survival [ Time Frame: Up to 5 years ]Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
- Median Progression Free Survival [ Time Frame: Up to 5 years ]Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
- Percentage of Participants With Treatment Response [ Time Frame: Up to 5 years ]Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites.
- Tumor Vasculature [ Time Frame: Up to 2 months ]Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886235
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Joseph Skitzki||Roswell Park Cancer Institute|