NIR-Guided Sentinel Lymph Node Mapping in Melanoma

NCT01121718 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 10-039
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Melanoma

Keywords

lymph node

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

ICG Intervention

EXPERIMENTAL

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

Interventions

ICG Intervention DRUG

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

Also known as: NIR fluorescence imaging, Sentinel Lymph Node

ICG Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Yolonda Colson, MD, PhD

  Dana Faber Cancer Institute / Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This study does not involve any masking.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is an experimental study. All study subjects will receive the same intervention.

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 12, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

US (2)