Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue
The issue of elective lymph node dissection (LND) in the management of melanoma patients
with clinically negative nodes remains controversial. The concept of elective LND is
attractive because it provides the opportunity to detect and remove occult micrometastases
before they become clinically apparent. Numerous retrospective analyses have consistently
shown a 15-20% long term survival advantage in patients undergoing elective LND who are
found to have positive nodes, compared to those undergoing therapeutic LND for clinically
positive nodes. The majority of patients undergoing elective LND however, do not have lymph
node involvement, and the impact of removal of these negative nodes on the survival of these
patients is unknown. The substantial morbidity of these procedures has led to the conduct of
a number of important prospective randomized trials designed to define the impact of
elective LND on the survival of patients with clinically node negative melanoma. In 1982,
the World Health Organization reported on the end results of 553
The primary objective of this protocol is to establish the feasibility of lymph node
mapping, using preoperative lymphoscintigraphy and intraoperative blue dye injection to
detect the sentinel node in patients at risk for regional lymph node metastasis from their
primary melanoma.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
This is a trial to assess the feasibility of the technique of identifying the sentinel node using the technique of lymphatic mapping as described by Morton. The primary endpoint of the trial will be success or failure in identifying the sentinel node.
18 years 1 month
No
Daniel Coit, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
91-015
NCT00581698
January 1991
September 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |