drugset / Trial / 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
NaSingle-groupOpen-labelDiagnostic
Summary
Open label, non-randomized, multi-center, within-subject comparative study to evaluate the tolerability and the diagnostic utility of Lymphoseek with optional comparison to VBD in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from neonatal through 17 years.
Timeline
- Start
- 2015-08
- Primary completion
- 2019-03-06
- Completion
- 2019-03-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tc99m tilmanocept | Diagnostic / imaging agent | 50 ug | Intrathecal |
| Subject | Tc99m tilmanocept | Diagnostic / imaging agent | 18.5 mbq | Intrathecal |
| Background | Vital Blue Dye | Diagnostic / imaging agent | 1 ml | Intrathecal |
| Background | Vital Blue Dye | Diagnostic / imaging agent | 3 ml | Intrathecal |