Status:
COMPLETED
Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Stage IA Skin Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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). (Par...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01886235
Start Date
September 4 2013
End Date
May 6 2020
Last Update
August 7 2020
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263