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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
24
A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery
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).
Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection
Nemours Children's Specialty Care
Jacksonville, Florida, United States
Nemours Children's Hopsital
Orlando, Florida, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Average Number of Lymph Nodes Identified Intraoperatively Per Subject
Time frame: 1 Day
Subject Localization Rates
The proportion of subjects with Lymphoseek-identified lymph nodes
Time frame: 1 Day
Proportion of Subjects Who Underwent Preoperative SPECT or SPECT/CT
Time frame: 1 Day
Proportion of Subjects With a Lymph Node Identified Preoperatively Using SPECT or SPECT/CT
Time frame: 1 day
Average Number of Lymph Nodes Identified Preoperatively Using SPECT or SPECT/CT Per Subject
Time frame: 1 Day
Agreement of the Number of Nodes Identified by Preoperative SPECT or SPECT/CT to Intraoperative Localization
Average difference in number of LNs identified preoperatively with SPECT/CR and number of LNs identified intraoperatively per subject
Time frame: 1 Day
Upstaging
The proportion of patients with pathology-positive lymph nodes who had at least one pathology-positive lymph node that was identified by Lymphoseek and had no other pathology-positive lymph nodes (i.e., identified by any other method)
Time frame: 1 Day
Nodal False Negative Rate for Nodes Identified
The number of pathology-positive lymph nodes that were missed intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent. Population is all subjects with pathology-positive nodes. False negative rate represents the failure rate of the mapping agent to identify sentinel lymph nodes.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Time frame: 1 Day
Nodal Sensitivity
The number of pathology-positive lymph nodes that were identified intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent. Population is all subjects with pathology-positive nodes. Sensitivity rate represents the success rate of the mapping agent to identify sentinel lymph nodes.
Time frame: 1 Day
Nodal Agreement of Central Pathology Assessment With Local Pathology Assessment of the Excised Lymph Node(s) to Confirm the Presence/Absence of Tumor Metastases
Number of nodes whose local and central pathology results agree divided by the number of nodes with nonmissing local and central pathology results
Time frame: 1 Day
Change in Subject Nodal Staging Before and After Surgery Based Upon Nodes Identified
Change in subject nodal staging was assessed via shift tables to show the number of subjects with each combination of presurgery and postsurgery nodal staging. Presurgery staging was based on standard-of-care clinical assessment. Postsurgery staging was based on the pathology results of the nodes identified.
Time frame: 1 Day
Number of Changes in Postsurgical Treatment Plan in Relation to Nodes Identified by Lymphoseek
Changes to postsurgical treatment plan will be compared to baseline treatment plan.
Time frame: 1 Day