A Pilot Study of Feasibility of Performing Intravital Microscopy in Melanoma Patients
Overview
- Phase
- N/A
- Intervention
- Laboratory Biomarker Analysis
- Conditions
- Recurrent Melanoma
- Sponsor
- Roswell Park Cancer Institute
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility 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)
Arms & Interventions
Diagnosis (intravital microscopy)
Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Intervention: Laboratory Biomarker Analysis
Diagnosis (intravital microscopy)
Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Intervention: Diagnostic Microscopy
Diagnosis (intravital microscopy)
Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Intervention: Fluorescein Sodium Injection
Diagnosis (intravital microscopy)
Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Intervention: Therapeutic Conventional Surgery
Outcomes
Primary Outcomes
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 Outcomes
- Median Overall Survival(Up to 5 years)
- Median Progression Free Survival(Up to 5 years)
- Complication Rate(Up to 5 years)
- Percentage of Participants With Treatment Response(Up to 5 years)
- Tumor Vasculature(Up to 2 months)
- "Percentage of Participants With Any Adverse Event(Up to 5 years)
- Blood Flow Rates(Up to 2 months)