Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery

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Roswell Park Comprehensive Cancer Center

Status

Completed

Conditions

Stage IIB Skin Melanoma
Stage IIIA Skin Melanoma
Stage IB Skin Melanoma
Stage IV Skin Melanoma
Stage IIA Skin Melanoma
Recurrent Melanoma
Stage IIIC Skin Melanoma
Stage IA Skin Melanoma
Stage IIC Skin Melanoma
Stage IIIB Skin Melanoma

Treatments

Procedure: Diagnostic Microscopy
Procedure: Therapeutic Conventional Surgery
Drug: Fluorescein Sodium Injection
Other: Laboratory Biomarker Analysis

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01886235
P30CA016056 (U.S. NIH Grant/Contract)
I 231512 (Other Identifier)
NCI-2013-01052 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Diagnosis (intravital microscopy)
Experimental group
Description:
Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Treatment:
Other: Laboratory Biomarker Analysis
Drug: Fluorescein Sodium Injection
Procedure: Therapeutic Conventional Surgery
Procedure: Diagnostic Microscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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