Anti-GD2-800CW imaging to highlight neuroblastoma during surgery
A Phase Ib/II First-in-human Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma
This trial will test whether a fluorescent antibody called anti-GD2-800CW can safely help surgeons see and remove neuroblastoma in children ages 1 to 18.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Princess Maxima Center for Pediatric Oncology Academic / other |
| Drugs / interventions | Dinutuximab, chemotherapy, Immunotherapy |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT07399821 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 1 to 18 with histologically confirmed neuroblastoma who are scheduled for surgical resection and have not previously received dinutuximab-beta are ideal candidates.
Not a fit: Patients who have received prior dinutuximab-beta, are pregnant or breastfeeding, or are not undergoing surgery are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, the agent could help surgeons see tumor tissue more clearly during operations, reducing complications and leftover tumor.
How similar studies have performed: Fluorescence-guided surgery has improved intraoperative tumor visualization in several adult cancers and early work with GD2-targeting agents supports feasibility, but using anti-GD2-800CW in pediatric neuroblastoma is early-phase and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Utrecht
- Prinses Maxima Centrum — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Marieke Kietselaer
- Email: trialmanagement@prinsesmaximacentrum.nl
- Phone: +31 88 972 7272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.