Drug updated on 12/11/2024
| Dosage Form | Injection (intradermal, subcutaneous, subareolar, or peritumoral; 92.5 MBq (2.5 mCi) and 250 mcg of technetium Tc 99m tilmanocept) |
| Drug Class | Radioactive diagnostic agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated with or without scintigraphic imaging for lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management
- Indicated with or without scintigraphic imaging for guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Latest News
Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- For breast cancer, the preoperative detection rate of (99m)Tc-tilmanocept was 0.94 (95% confidence interval (CI), 0.88-1.01) and the intraoperative detection rate was 0.99 (95% CI, 0.98-1.00), indicating high effectiveness in identifying sentinel nodes.
- In melanoma, the preoperative detection rate was 0.98 (95% CI, 0.96-0.99) and the intraoperative detection rate was 1.00 (95% CI, 0.99-1.00), with a sensitivity for nodal metastasis of 0.97 (95% CI, 0.92-1.03), demonstrating strong performance in this population.
- For head and neck cancer, the preoperative detection rate was 0.97 (95% CI, 0.93-1.02) and the intraoperative detection rate was 0.99 (95% CI, 0.96-1.01), supporting the use of (99m)Tc-tilmanocept in this cohort as well.
- The safety profile of (99m)Tc-tilmanocept is not detailed in the provided study, and there are no reported adverse effects or specific safety concerns associated with its use.
- The study does not offer safety comparisons to other drugs or specific information regarding adverse events in the studied populations (breast cancer, melanoma, and head and neck cancer).
- The studies included patients with breast cancer, melanoma, and head and neck cancer, demonstrating high detection rates for sentinel node mapping: breast cancer (preoperative detection rate 0.94, intraoperative 0.99), melanoma (preoperative 0.98, intraoperative 1.00), and head and neck cancer (preoperative 0.97, intraoperative 0.99), indicating the potential utility of (99m)Tc-tilmanocept in these populations.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Lymphoseek (technetium Tc 99m tilmanocept) Prescribing Information. | 2023 | Cardinal Health, Dublin, OH |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| (99m)Tc-Tilmanocept performance for sentinel node mapping in breast cancer, melanoma, and head and neck cancer: a systematic review and meta-analysis from a European expert panel | 2023 | European Journal of Nuclear Medicine and Molecular Imaging |