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Completed

NCT Number: NCT01121718

NIR-Guided Sentinel Lymph Node Mapping in Melanoma

This study will try to define an appropriate dose of the investigational drug indocyanine green (ICG) in combination with near infrared (NIR) imaging to use for future studies.

ICG is a dye which has been in use since the 50s, and is approved for testing liver function and measuring blood flow from the heart. It has been used in studies to map lymphatic pathways in lung and breast cancer and information from those studies suggest it may help identify lymph nodes associated with melanoma. ICG can be detected within the body using near-infrared light cameras.

In this study the investigators are looking at how easily ICG can get to the first lymph node (sentinel lymph node [SLN]) associated with melanoma, whether the investigators can see the path of the ICG and the SLN using a near infrared camera, and what dose of ICG works the best. While the current method for SNL mapping, known as lymphoscintigraphy, is effective it does provide a small amount of radiation. This study will compare the investigators results to the standard procedure.

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Key information

Conditions

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

Phase 1

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

At the time of surgery, you will undergo a lymphoscintigraphic procedure which is standard of care for patients with melanoma. You will also receive a dose of ICG mixed with human serum albumin. This will be administered in four small injections immediately around your tumor or the tumor scar if it has already been removed. Pictures of the ICG solution will be taken with the NIR camera and the progression of the dye along the lymphatic channel from your tumor to the SLN will be monitored.

As each lymph node is removed, pictures will be taken to see if the ICG dye has entered and colored that node. We will compare this technique with the results from the lymphoscintigraphy to measure accuracy.

Patients will be followed for at least one hour post injection for adverse events. The patient will then be taken off of the study. The results from each intervention will subsequently analyzed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed melanoma and an appropriate surgical candidate for a sentinel lymph node biopsy
  • Stage of disease conducive to sentinel lymph node biopsy as determined by oncologic surgeon
  • Receiving a planned lymphoscintigraphy procedure

Exclusion criteria

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy
  • Pregnant or breast-feeding

Treatment and study plan

ICG Intervention

Drug

NIR-guided sentinel lymph node mapping with indocyanine green (ICG)

Other names: NIR fluorescence imaging, Sentinel Lymph Node

Primary outcomes

  1. Feasibility

    Time frame: We will analyze data immediately following each case, and analyze all collected data at 6 month intervals

    To determine the feasibility of real-time intraoperative NIR lymphatic mapping with concurrent identification of the sentinel lymph node in human melanoma using indocyanine green.

Secondary outcomes

  1. Comparison of SLN identification rate between near-infrared mapping and lymphoscintigraphy.

    Time frame: We will analyze data immediately following each case, and analyze all collected data at 6 month intervals

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Beth Israel Deaconess Medical Center

Registry information

Official study title

Real-Time NIR-Guided Sentinel Lymph Node Mapping in Melanoma

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 12, 2010
Registry last updated
Feb 3, 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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