Trial record 1 of 1 for:    NCT01886235
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Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery

This study is currently recruiting participants.
Verified March 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01886235
First received: May 30, 2013
Last updated: March 6, 2014
Last verified: March 2014

May 30, 2013
March 6, 2014
September 2013
April 2016   (final data collection date for primary outcome measure)
Feasibility of performing intravital microscopy on accessible human melanoma tumors during standard local excision [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01886235 on ClinicalTrials.gov Archive Site
  • Adverse event rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Described using upper one-sided 95% Clopper Pearson confidence limits.
  • Complication rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Described using upper one-sided 95% Clopper Pearson confidence limits.
  • Tumor vasculature [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Associations between tumor characteristics and treatment response will be assessed using Logistic Regression methods.
  • Time to progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Adverse event rate [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
    Described using upper one-sided 95% Clopper Pearson confidence limits.
  • Complication rate [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
    Described using upper one-sided 95% Clopper Pearson confidence limits.
  • Tumor vasculature [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Associations between tumor characteristics and treatment response will be assessed using Logistic Regression methods.
  • Time to progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
 
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 intravital microscopy, may determine the extent of melanoma.

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 periodically for 5 years.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Recurrent Melanoma
  • Stage IA Melanoma
  • Stage IB Melanoma
  • Stage IIA Melanoma
  • Stage IIB Melanoma
  • Stage IIC Melanoma
  • Stage IIIA Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma
  • Drug: fluorescein sodium injection
    Given IV
    Other Name: Fluorescite
  • Procedure: diagnostic microscopy
    Undergo intravital microscopy
  • Procedure: therapeutic conventional surgery
    Undergo surgery
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Diagnosis (intravital microscopy)
Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Interventions:
  • Drug: fluorescein sodium injection
  • Procedure: diagnostic microscopy
  • Procedure: therapeutic conventional surgery
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
April 2016   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Not Provided
United States
 
NCT01886235
I 231512, NCI-2013-01052, I 231512, P30CA016056
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Joseph Skitzki Roswell Park Cancer Institute
Roswell Park Cancer Institute
March 2014

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