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An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
Sponsor: Princess Maxima Center for Pediatric Oncology
Summary
This is a non-randomized, open label phase Ib/II dose-escalation and expansion study designed to define the recommended dose of anti-GD2-800CW in pediatric neuroblastoma patients. The aim of this imaging study is to determine a safe and effective dose of anti-GD2-800CW for intra-operative detection of neuroblastoma using NIR fluorescence.
Official title: A Phase Ib/II First-in-human Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2025-11-05
Completion Date
2027-05-01
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
anti-GD2-800CW
Participants will receive a single dose of anti-GD2-800CW 96 hours prior to surgery. In phase Ib, using a 3+3 design, a dose escalation is performed to determine the RP2D.
Locations (1)
Prinses Maxima Centrum
Utrecht, Netherlands