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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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01886235
First received: May 30, 2013
Last updated: May 9, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Feasibility of Performing Intravital Microscopy in Melanoma Patients

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • "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. Data will be correlated with findings from the one-time, initial intravital microscopy observation for the defined 5-year period of data collection.

  • Median Progression Free 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.

  • 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.


Enrollment: 10
Actual Study Start Date: September 4, 2013
Estimated Study Completion Date: June 16, 2018
Primary Completion Date: June 16, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Given IV
Other Name: Fluorescite
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Therapeutic Conventional Surgery
Undergo surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886235

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Joseph Skitzki Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01886235     History of Changes
Other Study ID Numbers: I 231512
NCI-2013-01052 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 231512 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( US NIH Grant/Contract Award Number )
Study First Received: May 30, 2013
Results First Received: March 30, 2017
Last Updated: May 9, 2017

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on June 26, 2017