Clinical Trial: A Study Comparing Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Prospective, Open-Label, Multicenter Study Comparing Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Pediatric Patients With Melanoma, Rhabdomyosarco

Brief Summary: Open label, non-randomized, multi-center, within-subject comparative study to evaluate the tolerability and the diagnostic utility of Lymphoseek and compared with VBD in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from neonatal through 17 years.

Detailed Summary:
Sponsor: Cardinal Health 414, LLC

Current Primary Outcome: Nodal Concordance (the proportion of the number of lymph nodes identified by Tc99m tilmanocept and vital blue dye compared to the number of lymph nodes identified by vital blue dye) [ Time Frame: 1 Day ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reverse nodal concordance (the proportion of the number of lymph nodes identified by Tc99m tilmanocept and vital blue dye compared to the number of lymph nodes identified by Tc99m tilmanocept) [ Time Frame: 1 Day ]
  • Per subject concordance (the proportion of the number of subjects whose lymph nodes were identified by Tc99m tilmanocept and vital blue dye compared to the number of subjects with at least one lymph node identified by vital blue dye) [ Time Frame: 1 Day ]
  • Per subject reverse concordance (the proportion of the number of subjects whose lymph nodes were identified by Tc99m tilmanocept and vital blue dye compared to the number of subjects with at least one lymph node identified by Tc99m tilmanocept) [ Time Frame: 1 day ]
  • Number of Lymphoseek positive lymph nodes identified in surgery compared to SPECT/CT [ Time Frame: 1 day ]
  • Incidence of adverse events [ Time Frame: 7 days ]


Original Secondary Outcome: Same as current

Information By: Cardinal Health 414, LLC

Dates:
Date Received: July 24, 2015
Date Started: August 2015
Date Completion: September 2017
Last Updated: May 2, 2017
Last Verified: March 2017