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N/A Completed 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
Source: ClinicalTrials.gov NCT01886235 ↗
Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Jun 2017
Primary outcomePrimary: Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision — 70 percentage of participants

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.

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
— —

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. Informational only — not medical advice.

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