LYMPHOSEEK (tilmanocept), radiopharmaceutical for diagnostic use
Reason for request
High clinical benefit in the detection of sentinel nodes, but no demonstrated clinical advantage over NANOCIS, NANOCOLL or ROTOP-Nano-HSA.
LYMPHOSEEK is authorized for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity..
It plays the same role in the therapeutic strategy than NANOCOLL, NANOCIS and ROTOP-Nano-HSA depending on indications, when SN detection is necessary.
In squamous cell carcinoma of the oral cavity, the rate of false negatives with LYMPHOSEEK was of 2.56%, below the threshold of 14%predetermined from the literature.
In breast cancer and melanoma, the diagnostic performance established versus patent blue showed a node-level concordance rate of more than 90%, along with an exploratory false negative rate of between 0 and 7.3%, depending on the study.
Clinical Benefit
Substantial |
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Clinical Added Value
no clinical added value |
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