Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02509598 | A Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping | PHASE2 | COMPLETED | 24 | — | — | Aug 1, 2015 | Mar 6, 2019 | Jun 28, 2024 | 6 | United States |
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...