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Completed

NCT Number: NCT01898403

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

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.

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Key information

Conditions

Recurrent Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine Green Solution

Drug

Administered peri-tumoral and intradermally

Other names: IC-GREEN (ICG), ICG solution

Isosulfan blue (ISB)

Drug

Administered peri-tumoral and intradermally

Other names: Lymphazurin, N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide

Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)

Diagnostic Test

Other names: TSC lymph node mapping

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 12, 2013
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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