NIR-Guided Sentinel Lymph Node Mapping in Melanoma

Real-Time 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.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Drug: ICG Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ICG Intervention; Intraoperative NIR fluorescence imaging was performed after injection of 1.0 ml of 100 µM, 250 µM or 500 µM of ICG:HSA in four quadrants around the primary lesion. (The intervention to be administered is the ICG.)	Drug: ICG Intervention; NIR-guided sentinel lymph node mapping with indocyanine green (ICG); Other Names: Sentinel Lymph Node; NIR fluorescence imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	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.	We will analyze data immediately following each case, and analyze all collected data at 6 month intervals

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of SLN identification rate between near-infrared mapping and lymphoscintigraphy.	We will analyze data immediately following each case, and analyze all collected data at 6 month intervals

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Yolonda Colson, MD, PhD, Dana Faber Cancer Institute / Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: May 6, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (ESTIMATE): May 12, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: lymph node
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 10-039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this time, a plan is not in place to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No