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10.1245/s10434-006-9099-4
Annals of Surgical Oncology 14:913-921 (2007)
© 2007 Society of Surgical Oncology
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Original Article

Lymphoseek: A Molecular Imaging Agent for Melanoma Sentinel Lymph Node Mapping

Anne M. Wallace, MD, FACS1,2, Carl K. Hoh, MD2,3, Scott J. Ellner, DO1,2, Denise D. Darrah, RN2, Gery Schulteis, PhD4 and David R. Vera, PhD2,3

1 Department of Surgery, University of California, San Diego, 200 West Arbor Drive, San Diego, California 92103, USA
2 Moores UCSD Cancer Center, University of California, San Diego, 3855 Health Sciences Drive, La Jolla, California 92093, USA
3 Division of Nuclear Medicine, University of California, San Diego, 200 West Arbor Drive, San Diego, California 92103, USA
4 Department of Anesthesiology, University of California, San Diego, 9500 Gilman Drive, La Jolla, California 92093, USA

Correspondence: Address correspondence and reprint requests to: Anne M. Wallace, MD, FACS; E-mail: amwallace{at}ucsd.edu

Background: Lymphoseek is a molecular imaging agent specifically designed for sentinel lymph node mapping. We conducted a phase I clinical trial in which Lymphoseek was compared with filtered [99mTc]sulfur colloid (fTcSC) for melanoma sentinel lymph node detection.

Methods: Twenty-four patients (33–81 years) with melanoma participated in this study. Four groups of six patients received an intradermal administration (.5 mCi) of 1.0, 5.0, or 10.0 nmol of 99mTc-labeled Lymphoseek or filtered [99mTc]sulfur colloid. The injection site clearance was monitored by nuclear imaging for 3 hours. Lymph nodes obtained by gamma-guided biopsy (4.0–8.7 hours after injection) were assayed for radioactivity. Clinical chemistry values were monitored (before injection, before surgery, and 4 and 24 hours), and whole-body scans were acquired at 1 and 12 hours after injection.

Results: Lymphoseek exhibited a significantly (P < .001) faster injection site clearance at all dose levels. The mean Lymphoseek clearance half-time was 2.17 ± .96 hours (n = 18) compared with 14.7 ± 6.3 hours for fTcSC (n = 6). The mean sentinel lymph node uptakes of Lymphoseek (.73% ± .94%) and fTcSC (.85% ± 1.19%) were statistically equivalent (P = .68). Lymphoseek exhibited a lower mean number of sentinel lymph nodes per basin (1.6) than fTcSC (1.9). No adverse events were observed, nor were any clinically significant alterations in laboratory parameters. Radiation absorbed doses were lower than filtered [99mTc]sulfur colloid.

Conclusions: The molecular imaging agent Lymphoseek demonstrated faster injection site clearance and equivalent primary sentinel node uptake when compared with filtered [99mTc]sulfur colloid.

Key Words: Sentinel lymph node biopsy • Radiopharmaceutical • [99mTc]DTPA-mannosyl-dextran • Lymphoseek • Molecular imaging • Melanoma






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