Anti-GD2-800CW imaging to highlight neuroblastoma during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label phase Ib/II dose-escalation and expansion trial testing anti-GD2-800CW, a near-infrared fluorescent antibody, for intraoperative visualization of neuroblastoma. Children scheduled for standard-of-care tumor resection will receive a single dose of the agent before surgery and surgeons will use NIR fluorescence imaging to locate tumor tissue during the operation. The study will define a recommended imaging dose based on safety, tolerability, and intraoperative tumor detection performance. It is non-randomized and conducted at the Princess Maxima Centrum for Pediatric Oncology.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Previous treatment with Dinutuximab-beta, either alone or in combination with chemotherapy
* 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.
* 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.

Where it's running

• Prinses Maxima Centrum
  Utrecht, Netherlands Recruiting

Study contacts

• Study coordinator: Marieke Kietselaer
• Email: trialmanagement@prinsesmaximacentrum.nl
• Phone: +31 88 972 7272

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.