Clinical trial NCT01121718: NIR-Guided Sentinel Lymph Node Mapping in Melanoma
Official title: Real-Time NIR-Guided Sentinel Lymph Node Mapping in Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Keywords: lymph node
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2010-05-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an experimental study. All study subjects will receive the same intervention.
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Feasibility
timeFrame: We will analyze data immediately following each case, and analyze all collected data at 6 month intervals
Secondary outcomes:
measure: Comparison of SLN identification rate between near-infrared mapping and lymphoscintigraphy.
timeFrame: We will analyze data immediately following each case, and analyze all collected data at 6 month intervals
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Dana Faber Cancer Institute / Brigham and Women's Hospital
name: Yolonda Colson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: