Drug updated on 9/4/2024
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 lymphatic 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.
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Summary
- Lymphoseek (technetium Tc 99m tilmanocept) is 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 aged one month and older with solid tumors for which this procedure is a component of intraoperative management. It is also 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.
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Breast Cancer Patients: The preoperative detection rate (DR) is 0.94 (95% CI, 0.88-1.01), and the intraoperative DR is 0.99 (95% CI, 0.98-1.00).
- Melanoma Patients: The preoperative detection rate (DR) is 0.98 (95% CI, 0.96-0.99), the intraoperative DR is 1.00 (95% CI, 0.99-1.00), and the pooled sensitivity for nodal metastasis is 0.97 (95% CI, 0.92-1.03).
- Head and Neck Cancer Patients: The preoperative detection rate (DR) is 0.97 (95% CI, 0.93-1.02), and the intraoperative DR is 0.99 (95% CI, 0.96-1.01).
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Lymphoseek (technetium Tc 99m tilmanocept) Prescribing Information. | 2021 | Cardinal Health 414, LLC Dublin, OH |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
99mTc-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 |