Skip to main content
Log in

Lymphoseek: A Molecular Radiopharmaceutical for Sentinel Node Detection

Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background: Lymphoseek is a new radiopharmaceutical that accumulates in lymphatic tissue by binding to a receptor that resides on the surface of macrophage cells. We conducted a phase I clinical trial in which Lymphoseek was compared with filtered [99mTc]sulfur colloid (fTcSC) for sentinel node detection in patients with breast cancer.

Methods: Twelve women (42–71 years) with breast cancer were randomly assigned to a 3-hour imaging protocol with peritumoral/subdermal injections (.5 mCi) of either Lymphoseek (1 nmol; molecular weight, 28 kDa; diameter, .007 μm) or .2 μm of fTcSC. Serial images were acquired for 180 minutes. Sentinel nodes, excised within 4.2 to 7.3 hours of administration, were assayed in a dose calibrator.

Results: The receptor-binding agent, Lymphoseek, exhibited a significantly (P = .0025) faster injection site clearance (rate, .255 ± .147/hour; fTcSC rate, .014 ± .018/hour); the mean Lymphoseek clearance half-time was 2.72 ± 1.57 hours compared with 49.5 ± 38.5 hours for fTcSC. The primary sentinel node uptake of Lymphoseek (range, .02%–1.12%; mean, .55% ± .43%) and fTcSC (range, .00%–1.93%; mean, .65% ± .63%) did not differ (P = .75). Lymphoseek exhibited a lower mean number of sentinel nodes per study (n = 1.3) than fTcSC (n = 1.7) and a higher concordance with Lymphazurin.

Conclusions: The molecular receptor-binding agent Lymphoseek demonstrated faster injection site clearance and equivalent primary sentinel node uptake when compared with fTcSC.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

REFERENCES

  1. Stern H, McAfee J, Subramanian G. Preparation, distribution and utilization of technetium-99m sulfur colloid. J Nucl Med 1966; 7: 655–75.

    Google Scholar 

  2. Larson S, Nelp W. Radiopharmacology of a simplified technetium-99m colloid preparation for photoscanning. J Nucl Med 1966; 7: 817–26.

    Google Scholar 

  3. Sacks GA, Sandler MP, Born ML. Lymphoscintigraphy as an adjunctive procedure in the perioperative assessment of patients undergoing microlymphaticovenous anastomoses. Clin Nucl Med 1983; 8: 309–11.

    Google Scholar 

  4. Hung JC, Wiseman GA, Wahner HW, et al. Filtered technetium-99m-sulfur colloid evaluated for lymphoscintigraphy. J Nucl Med 1995; 36: 1895–901.

    Google Scholar 

  5. Uren R, Thompson JF, Howman-Giles RB. Lymphatic Drainage of the Skin and Breast. Singapore: Harwood Academic Publishers, 1999.

    Google Scholar 

  6. Nieweg OE, Essner R, Reintgen DS, Thompson JF, eds. Lymphatic Mapping and Probe Applications in Oncology. New York: Marcel Dekker, 2000.

    Google Scholar 

  7. Mariani G, Moresco L, Viale G, et al. Radioguided sentinel lymph node biopsy in breast cancer surgery. J Nucl Med 2001; 42: 1198–215.

    Google Scholar 

  8. Vera DR, Wallace AM, Hoh CK, Mattrey RF. A synthetic macromolecule for sentinel node detection: [99mTc]DTPA-mannosyl-dextran. J Nucl Med 2001; 42: 951–9.

    Google Scholar 

  9. Steer CJ, Ashwell G. Receptor-Mediated Endocytosis: Mechanisms, Biologic Function, and Molecular Properties. 2nd ed. Philadelphia: WB Saunders, 1990.

    Google Scholar 

  10. Hoh CK, Wallace AM, Vera DR. Preclinical studies of [99mTc]- DPTA-mannosyl-dextran. Nucl Med Biol 2003; 30: 457–64.

    Google Scholar 

  11. Robbins PJ. Chromatography of Technetium-99m Radiopharmaceuticals—A Practical Guide. New York: The Society of Nuclear Medicine, 1984.

    Google Scholar 

  12. Bevington PR. Data Reduction and Error Analysis for the Physical Sciences. New York: McGraw-Hill, 1969.

    Google Scholar 

  13. U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry: Developing Medical Imaging Drugs and Biological Products. Rockville, MD: US Department of Health and Human Services, 2000.

    Google Scholar 

  14. Gulec S, Moffat FL, Carroll RG, et al. Sentinel lymph node localization in early breast cancer. J Nucl Med 1998; 39: 1388–93.

    Google Scholar 

  15. McMasters KM, Wong SL, Martin RCG II, et al. Dermal injection of radioactive colloid is superior to peritumoral injection for breast cancer sentinel lymph node biopsy: results of a multiinstitutional study. Ann Surg 2001; 233: 676–87.

    Article  CAS  PubMed  Google Scholar 

  16. Krag DN, Weaver DL, Alex JC, Fairbank JT. Surgical re-section and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol 1993; 2: 335–9.

    Article  CAS  PubMed  Google Scholar 

  17. Vera DR, Krohn KA, Stadalnik RC, Scheibe PO. Tc-99m galactosyl-neoglycoalbumin: in vitro characterization of receptor-mediated binding. J Nucl Med 1984; 25: 779–87.

    Google Scholar 

  18. Veronesi U, Paganelli G, Galemberti V, et al. Sentinel-node biopsy to avoid axillary dissection in breast cancer with clinically negative lymph-nodes. Lancet 1997; 349: 1864–7.

    Article  CAS  PubMed  Google Scholar 

  19. Albertini J, Lyman GH, Cox C, et al. Lymphatic mapping and sentinel node biopsy and lymphatic mapping of patients with breast cancer. JAMA 1996; 276: 1818–22.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Anne M. Wallace MD.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Wallace, A.M., Hoh, C.K., Vera, D.R. et al. Lymphoseek: A Molecular Radiopharmaceutical for Sentinel Node Detection. Ann Surg Oncol 10, 531–538 (2003). https://doi.org/10.1245/ASO.2003.07.012

Download citation

  • Received:

  • Accepted:

  • Issue Date:

  • DOI: https://doi.org/10.1245/ASO.2003.07.012

Key Words

Navigation