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A Phase 2 Study of 99mTc-Tilmanocept in the Detection of Sentinel Lymph Nodes in Melanoma and Breast Cancer

  • Melanomas
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Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Several 99mTc-labeled agents that are not approved by the U.S. Food and Drug Administration are used for lymphatic mapping. A new low-molecular-weight mannose receptor–based, reticuloendothelial cell-directed, 99mTc-labeled lymphatic imaging agent, 99mTc-tilmanocept, was used for lymphatic mapping of sentinel lymph nodes (SLNs) from patients with primary breast cancer or melanoma malignancies. This novel molecular species provides the basis for potentially enhanced SLN mapping reliability.

Methods

In a prospectively planned, open-label phase 2 clinical study, 99mTc-tilmanocept was injected into breast cancer and cutaneous melanoma patients before intraoperative lymphatic mapping. Injection technique, preoperative lymphoscintigraphy (LS), and intraoperative lymphatic mapping with a handheld gamma detection probe were performed by investigators per standard practice.

Results

Seventy-eight patients underwent 99mTc-tilmanocept injection and were evaluated (47 melanoma, 31 breast cancer). For those whom LS was performed (55 patients, 70.5%), a 99mTc-tilmanocept hot spot was identified in 94.5% of LS patients before surgery. Intraoperatively, 99mTc-tilmanocept identified at least one regional SLN in 75 (96.2%) of 78 patients: 46 (97.9%) of 47 in melanoma and 29 (93.5%) of 31 in breast cancer cases. Tissue specificity of 99mTc-tilmanocept for lymph nodes was 100%, displaying 95.1% mapping sensitivity by localizing in 173 of 182 nodes removed during surgery. The overall proportion of 99mTc-tilmanocept-identified nodes that contained metastatic disease was 13.7%. Five procedure-related serious adverse events occurred, none related to 99mTc-tilmanocept.

Conclusions

Our results demonstrate the safety and efficacy of 99mTc-tilmanocept for use in intraoperative lymphatic mapping. The high intraoperative localization and lymph node specificity of 99mTc-tilmanocept and the identification of metastatic disease within the nodes suggest SLNs are effectively identified by this novel mannose receptor–targeted molecule.

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Acknowledgment

The authors acknowledge Statking Consulting Inc. (Fairfield, OH) for support in statistical analysis. This work was partially supported by the National Institutes of Health grant K23 CA109115-01A3 (to JK). The authors declare financial interest and/or investment in the sponsoring company, Neoprobe Corporation.

Conflicts of Interest

None.

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Authors and Affiliations

  1. California Pacific Medical Center and Sutter Pacific Medical Foundation and Research Institute, University of California, San Francisco, CA, USA

    Stanley P. L. Leong MD

  2. University Hospitals Case Medical Center, Cleveland, OH, USA

    Julian Kim MD

  3. Department of Surgical Oncology, M. D. Anderson Cancer Center, Houston, TX, USA

    Merrick Ross MD

  4. John Wayne Cancer Institute, Santa Monica, CA, USA

    Mark Faries MD

  5. Department of Surgery, University of Louisville, Louisville, KY, USA

    Charles R. Scoggins MD, MBA

  6. Department of Clinical Research, Neoprobe Corporation, Dublin, OH, USA

    Wendy L. Rich Metz PhD, Frederick O. Cope PhD & Richard C. Orahood MD

Authors
  1. Stanley P. L. Leong MD
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  2. Julian Kim MD
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  5. Charles R. Scoggins MD, MBA
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Correspondence to Stanley P. L. Leong MD.

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Leong, S.P.L., Kim, J., Ross, M. et al. A Phase 2 Study of 99mTc-Tilmanocept in the Detection of Sentinel Lymph Nodes in Melanoma and Breast Cancer. Ann Surg Oncol 18, 961–969 (2011). https://doi.org/10.1245/s10434-010-1524-z

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  • DOI: https://doi.org/10.1245/s10434-010-1524-z

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