Ignite Creation Date:
2024-05-06 @ 7:16 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02509598
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2015-07-24
Brief Title:
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
Sponsor:
Cardinal Health 414 LLC
Organization:
Cardinal Health 414 LLC
Study Overview
Official Title:
A Prospective Open-Label Multicenter 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
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None