NIR-Guided Sentinel Lymph Node Mapping in Melanoma

2014-08-27 03:13:46 | BioPortfolio


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.


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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic




Sentinel Lymph Node Mapping


Brigham and Women's Hospital
United States


Not yet recruiting


Dana-Farber Cancer Institute

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:46-0400

Clinical Trials [1721 Associated Clinical Trials listed on BioPortfolio]

Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer

RATIONALE: Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metas...

Sentinel Node With Ultrasound Contrast in Melanoma

The purpose is to evaluate,in 20 patients, if the sentinel node(s) in melanoma can be detected by lymph contrast ultrasound. In comparing the patients will also get lymph-scintigraphy and ...

Sentinel Lymph Node Mapping in Detecting Cancer That Has Spread to Lymph Nodes in Patients With Non-Small Cell Lung Cancer

RATIONALE: Diagnostic procedures such as sentinel lymph node mapping may improve the ability to detect cancer that has spread to the lymph nodes. PURPOSE: This clinical trial is studying ...

Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer

RATIONALE: Diagnostic procedures, such as lymph node mapping and biopsy, may improve the ability to detect the extent of colorectal cancer. PURPOSE: Diagnostic trial to study the feasibil...

Study of Sentinel Lymph Node Biopsy for Conjunctival Melanoma and Sebaceous Cell Carcinoma of the Eyelid

The goal of this clinical research study is to localize the sentinel lymph node (SLN) (s) and biopsy it (them) to see if the patient has small or low volume metastatic disease that would o...

PubMed Articles [3633 Associated PubMed Articles listed on BioPortfolio]

Sentinel Node Biopsy in Melanoma: A Short Update.

Several controversies are still ongoing about sentinel node biopsy in melanoma. It is basically a staging procedure for melanoma > 0.75 mm in thickness or for thinner melanoma in the presence of ulcer...

Sentinel node mapping in vulvar carcinoma.

Vulvar cancer typically spreads through the inguinofemoral lymph nodes and traditionally en bloc resection of these nodes is performed as their status is an important prognostic factor. Sentinel lymph...

Predictors of Sentinel Lymph Node Positivity in Thin Melanoma Using the National Cancer Database.

Following melanoma excision, patients often receive sentinel lymph node biopsy (SLNB) for further staging. Limited data regarding predictors of SLNB positivity in thin melanoma are available.

Sentinel lymph node biopsy mapped with methylene blue dye alone in patients with breast cancer: A systematic review and meta-analysis.

Methylene blue dye is easy to obtain in developing countries and can be used in sentinel lymph node mapping for breast cancer. However, the accuracy of methylene blue alone for sentinel lymph node map...

Current management of regional lymph nodes in patients with melanoma.

The publication of recent randomized trials has prompted a significant shift in both our understanding and the management of patients with melanoma. Here, the current management of the regional lymph ...

Medical and Biotech [MESH] Definitions

First lymph node to receive drainage from the primary tumor. SENTINEL LYMPH NODE BIOPSY is performed to determine early METASTASIS status because cancer cells may appear first in the sentinel node.

A diagnostic procedure used to determine whether LYMPHATIC METASTASIS has occurred. The sentinel lymph node is the first lymph node to receive drainage from a neoplasm.

Malignant lymphoma in which the lymphomatous cells are clustered into identifiable nodules within the LYMPH NODES. The nodules resemble to some extent the GERMINAL CENTER of lymph node follicles and most likely represent neoplastic proliferation of lymph node-derived follicular center B-LYMPHOCYTES.

The local lymph node assay (LLNA) is an alternative method for the identification of chemicals that have the ability to cause skin sensitization and allergic contact dermatitis. Endpoints have been established so fewer animals are required and less painful procedures are used.

The historic designation for scrofula (TUBERCULOSIS, LYMPH NODE). The disease is so called from the belief that it could be healed by the touch of a king. This term is used only for historical articles using the name "king's evil", and is to be differentiated from scrofula as lymph node tuberculosis in modern clinical medicine. (From Webster, 3d ed)

More From BioPortfolio on "NIR-Guided Sentinel Lymph Node Mapping in Melanoma"

Quick Search


Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...

Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Searches Linking to this Trial