Objective: To develop a simple, minimally invasive technique of determ
ining whether regional node metastasis has occurred in patients with m
elanoma. Setting: Teaching hospital tertiary care and private practice
settings. Patients: Between February 1993 and October 1994, 121 patie
nts with invasive malignant melanoma and clinically negative lymph nod
es were enrolled in this clinical trial. Design: Consecutive sample cl
inical trial. Within 24 hours prior to lymph node resection, a radioac
tive tracer was injected into the dermis around the site of the primar
y melanoma. Forty-four patients also had blue dye injected immediately
prior to surgical resection. Measurement of radioactivity in the lymp
h nodes and surgical localization were made using a handheld gamma det
ector. Radiolabeled nodes were selectively removed with the least diss
ection possible. In patients with pathologically positive radiolabeled
nodes, regional lymphadenectomy was performed. Outcome Measures: Succ
essful identification of radiolabeled sentinel lymph nodes, correlatio
n of radiolabeling with injection of blue dye, and regional node recur
rence rate. Results: Surgeons successfully resected the radiolabeled s
entinel lymph nodes in 118 (98%) of 121 patients. One hundred percent
of blue-stained lymph nodes were successfully radiolabeled. Fifteen pa
tients had pathologically positive sentinel lymph nodes. In 10 patient
s, the sentinel node was the only node with metastasis. Two systemic a
nd one regional node recurrences occurred during a mean follow-up of 2
20 days. Conclusions: Selective gamma probe-guided resection of the ra
diolabeled sentinel lymph node is possible in over 95% of patients wit
h melanoma. This technique offers a simple and reliable method of stag
ing of regional lymph nodes in these patients without performing a reg
ional lymphadenectomy.