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N/A N=10 Diagnostic

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

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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