N/A
N=10
Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery
Recurrent Melanoma · Stage IA Skin Melanoma · Stage IB Skin Melanoma · Stage IIA Skin Melanoma · Stage IIB Skin Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01886235 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Jun 2017
Primary outcome: Primary: Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision — 70 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diagnostic Microscopy (Procedure); Fluorescein Sodium Injection (Drug); Laboratory Biomarker Analysis (Other); Therapeutic Conventional Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision |
70 | — |
| SECONDARY "Percentage of Participants With Any Adverse Event |
40 | — |
| SECONDARY Blood Flow Rates |
270 | — |
| SECONDARY Complication Rate |
— | — |
| SECONDARY Median Overall Survival |
NA | — |
| SECONDARY Median Progression Free Survival |
NA | — |
| SECONDARY Percentage of Participants With Treatment Response |
— | — |
| SECONDARY Tumor Vasculature |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of = 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)
Data sourced from ClinicalTrials.gov (NCT01886235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.