CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Tc99m tilmanocept +2 moredrug
Likely dose
Vital Blue Dye (optional) 3 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02509598
NCT02509598Phase 2Completed
CompareCT.gov

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

Cardinal Health 414, LLC·interventional·Posted Jul 28, 2015·Updated Jun 28, 2024

In Brief

A Phase 2 clinical trial evaluating Tc99m tilmanocept, Vital Blue Dye (optional), and 1 other intervention for Rhabdomyosarcoma and Melanoma. Completed, enrolled 24 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhabdomyosarcoma, Melanoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 28, 2015
Enrollment StartAug 1, 2015
Primary CompletionMar 6, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.9 years ago

Interventions

Tc99m tilmanoceptdrug

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 Mappingprocedure

Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection