Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma

Overview

This clinical trial compares and contrasts lymph node mapping using indocyanine green (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC). Study participants with malignant melanoma will undergo all 3 evaluations to assess the extent of the spread of the melanoma.

Full Title of Study: “Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

Detailed Description

PRIMARY OBJECTIVES: I. To show that indocyanine green (ICG) (indocyanine green solution) is equal to both isosulfan blue (ISB) and technetium Tc 99m sulfur colloid (TSC) and will allow all lymph node mapping to occur in the operating room (OR). OUTLINE: Patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution. During surgery, patients undergo identification of the sentinel lymph node and imaging using a laser with videocamera (SPY Elite camera).

Interventions

  • Drug: Indocyanine green solution
    • Administered peri-tumoral and intradermally
  • Drug: Isosulfan blue (ISB)
    • Administered peri-tumoral and intradermally
  • Diagnostic Test: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)

Arms, Groups and Cohorts

  • Experimental: Sentinel Lymph Node (SLN) Detection
    • All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.

Clinical Trial Outcome Measures

Primary Measures

  • Sentinel Lymph Nodes (SLN) Mapping
    • Time Frame: Up to 1 year
    • Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.

Participating in This Clinical Trial

Inclusion Criteria

  • Ability to understand and willingness to sign informed consent document – Signed written informed consent – Malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB) – 18 years of age or older – Complete blood count (CBC) and metabolic panel within 6 months Exclusion Criteria:

  • History of hepatic or renal failure – Allergy to iodine containing products – Pregnant or may be pregnant – Psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements – Undergoing dialysis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ralph Greco, Johnson and Johnson Professor of Surgery – Stanford University
  • Overall Official(s)
    • Ralph Greco, Principal Investigator, Stanford University Hospitals and Clinics

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