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NIR-Guided Sentinel Lymph Node Mapping in Melanoma

This study has been completed.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Yolonda L. Colson, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01121718
First received: May 6, 2010
Last updated: February 2, 2017
Last verified: February 2017
  Purpose

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.


Condition Intervention Phase
Melanoma Drug: ICG Intervention Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
This is an experimental study. All study subjects will receive the same intervention.
Masking: None (Open Label)
Masking Description:
This study does not involve any masking.
Primary Purpose: Diagnostic
Official Title: Real-Time NIR-Guided Sentinel Lymph Node Mapping in Melanoma

Resource links provided by NLM:


Further study details as provided by Yolonda L. Colson, MD, PhD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: September 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • NIR fluorescence imaging
  • Sentinel Lymph Node

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121718

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Yolonda Colson, MD, PhD Dana Faber Cancer Institute / Brigham and Women's Hospital
  More Information

Responsible Party: Yolonda L. Colson, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01121718     History of Changes
Other Study ID Numbers: 10-039
Study First Received: May 6, 2010
Last Updated: February 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: At this time, a plan is not in place to make IPD available to other researchers.

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

Keywords provided by Yolonda L. Colson, MD, PhD, Dana-Farber Cancer Institute:
lymph node

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 17, 2017