Imaging Study of Anti-GD2-800CW to Detect Neuroblastoma During Surgery
Tests anti-GD2-800CW imaging to help find neuroblastoma during surgery in children.
Plain-language title generated from the registry record
Registry title: An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
Key facts
- Where
- Utrecht, NetherlandsSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 18 years old?
Source: NCT07399821, who can take part
Where in Netherlands
- Prinses Maxima Centrum voor Kinderoncologie B.V.Utrecht, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Princess Maxima Center for Pediatric Oncology
- Trial code
- NCT07399821EU 2023-507596-22-00
- Record updated
- 10 February 2026
- Original description
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.Read full original descriptionShow less
A Phase Ib/II First-in-human Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
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.
Inclusion: Patients with the diagnosis of neuroblastoma as defined by histopathology (confirmed by the PMC Department of Pathology), who will be operated for NB as standard of care procedure; Patients older than 1 year of age and not older than 18 years; Written informed consent from patients and/or from parents or legal guardians, according to local law and regulations.
Exclusion: Previous treatment with Dinutuximab-beta, either alone or in combination with chemotherapy; Sexually active participants not willing to use highly effective contraceptive method (pearl index <1) as defined in CTFG HMA 2020 (Appendix I) during trial participation and until 6 months after end of protocol therapy; Patients that received prior treatment with chimeric antibodies; Pregnancy or positive pregnancy test (urine or serum) in females of childbearing potential. Pregnancy test must be performed within during the screening period and before the administration of the IMP; Breast feeding.