Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tc99m tilmanocept · 1 trial · 2 indications
The proportion of subjects with Lymphoseek-identified lymph nodes
| Arm | Type | Description |
|---|---|---|
| Tc99m tilmanocept and Vital Blue Dye (optional) | EXPERIMENTAL | 0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). |
| Name | Type | Description |
|---|---|---|
| Tc99m tilmanocept | DRUG | A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery |
| Vital Blue Dye (optional) | DRUG | A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). |
| Lymph Node Mapping | PROCEDURE | Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection |
Inclusion Criteria: * The subject's parent(s)/legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. Where locally applicable, the subject also understands and voluntarily provides his/her assent prior t...
Tc99m tilmanocept is a small molecule radiopharmaceutical being studied for use in rhabdomyosarcoma, a type of cancer. It is being investigated as a lymphoid tissue targeting agent for lymph node mapping in pediatric patients with rhabdomyosarcoma, melanoma, or other solid tumors. It is currently in clinical development and is not approved for this indication.
Tc99m tilmanocept is being developed by Cardinal Health, Inc., which trades on the New York Stock Exchange under the ticker CAH. The company is conducting clinical research to evaluate the drug's potential use in oncology, specifically for lymph node mapping in certain pediatric cancers.
Tc99m tilmanocept is in Phase 2 clinical development for rhabdomyosarcoma. It is an investigational drug, meaning it has not been approved by regulatory authorities for this use. The Phase 2 trial has been completed, and the drug remains under investigation for its safety and effectiveness.
Tc99m tilmanocept has one completed clinical trial, identified as NCT02509598. This Phase 2 study evaluated the drug as a lymphoid tissue targeting agent in pediatric patients with melanoma, rhabdomyosarcoma, or other solid tumors undergoing lymph node mapping. The trial enrolled 24 participants in the United States.
Yes, Tc99m tilmanocept is also known as Lymphoseek. In clinical trials, it is referred to by this brand name, as seen in the study titled 'A Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients.' Both names refer to the same investigational drug.