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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 : Completed
First Posted : June 25, 2013
Results First Posted : June 6, 2017
Last Update Posted : August 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE May 30, 2013
First Posted Date  ICMJE June 25, 2013
Results First Submitted Date  ICMJE March 30, 2017
Results First Posted Date  ICMJE June 6, 2017
Last Update Posted Date August 7, 2020
Actual Study Start Date  ICMJE September 4, 2013
Actual Primary Completion Date June 16, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 21, 2013)
Feasibility of performing 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
  • "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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2013)
  • Adverse event rate [ Time Frame: Up to 30 days ]
    Described using upper one-sided 95% Clopper Pearson confidence limits.
  • Complication Rate [ Time Frame: Up to 30 days ]
    Described using upper one-sided 95% Clopper Pearson confidence limits.
  • 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.
  • 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.
  • Treatment response [ Time Frame: Up to 5 years ]
    Associations between tumor characteristics and treatment response will be assessed using Logistic Regression methods.
  • Time to progression [ Time Frame: Up to 5 years ]
    Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes. Data will be correlated with findings from the one-time, initial intravital microscopy observation for the defined 5-year period of data collection.
  • Survival [ Time Frame: Up to 5 years ]
    Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes. Data will be correlated with findings from the one-time, initial intravital microscopy observation for the defined 5-year period of data collection.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery
Official Title  ICMJE A Pilot Study of Feasibility of Performing Intravital Microscopy in Melanoma Patients
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Procedure: Diagnostic Microscopy
    Undergo intravital microscopy
  • Drug: Fluorescein Sodium Injection
    Given IV
    Other Name: Fluorescite
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Procedure: Therapeutic Conventional Surgery
    Undergo surgery
Study Arms  ICMJE Experimental: Diagnosis (intravital microscopy)
Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Interventions:
  • Procedure: Diagnostic Microscopy
  • Drug: Fluorescein Sodium Injection
  • Other: Laboratory Biomarker Analysis
  • Procedure: Therapeutic Conventional Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2017)
10
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2013)
30
Actual Study Completion Date  ICMJE May 6, 2020
Actual Primary Completion Date June 16, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01886235
Other Study ID Numbers  ICMJE I 231512
NCI-2013-01052 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 231512 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Joseph Skitzki Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP