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

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Abstract

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.

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Acknowledgments

The authors thank the Neoprobe Corporation (Dublin, OH) for the use of a model 2100 intraoperative radioisotope detector. Supported by the American Cancer Society (grant RSG-01-249-01). Lymphoseek is a registered trademark of the Neoprobe Corporation.

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Authors and Affiliations

  1. Department of Surgery, University of California, San Diego, 200 West Arbor Drive, San Diego, California, 92103, USA

    Anne M. Wallace MD, FACS & Scott J. Ellner DO

  2. Moores UCSD Cancer Center, University of California, San Diego, 3855 Health Sciences Drive, La Jolla, California, 92093, USA

    Anne M. Wallace MD, FACS, Carl K. Hoh MD, Scott J. Ellner DO, Denise D. Darrah RN & David R. Vera PhD

  3. Division of Nuclear Medicine, University of California, San Diego, 200 West Arbor Drive, San Diego, California, 92103, USA

    Carl K. Hoh MD & David R. Vera PhD

  4. Department of Anesthesiology, University of California, San Diego, 9500 Gilman Drive, La Jolla, California, 92093, USA

    Gery Schulteis PhD

Authors
  1. Anne M. Wallace MD, FACS
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  2. Carl K. Hoh MD
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  3. Scott J. Ellner DO
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  4. Denise D. Darrah RN
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  5. Gery Schulteis PhD
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  6. David R. Vera PhD
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Corresponding author

Correspondence to Anne M. Wallace MD, FACS.

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Wallace, A.M., Hoh, C.K., Ellner, S.J. et al. Lymphoseek: A Molecular Imaging Agent for Melanoma Sentinel Lymph Node Mapping. Ann Surg Oncol 14, 913–921 (2007). https://doi.org/10.1245/s10434-006-9099-4

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  • DOI: https://doi.org/10.1245/s10434-006-9099-4

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