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Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue


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Trial Information

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.


Inclusion Criteria:



- primary melanomas Clark III and Breslow thickness > 1 mm, or Clark IV-V and any
Breslow thickness

- clinically negative regional nodes

Exclusion Criteria:

- previous definitive wide local excision of the primary melanoma with skin graft

- an inflammatory lesion in the area of the primary melanoma that is likely to drain to
the same nodal basin

- pregnancy

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

18 years 1 month

Safety Issue:

No

Principal Investigator

Daniel Coit, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

91-015

NCT ID:

NCT00581698

Start Date:

January 1991

Completion Date:

September 2009

Related Keywords:

  • Melanoma
  • Melanoma
  • Negative regional lymph nodes
  • Primary melanomas Clark III and Breslow thickness > 1 mm, or Clark
  • IV-V and any Breslow thickness, and clinically negative regional nodes
  • Melanoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021