Neuroblastoma
Conditions
Brief summary
Anti-GD2-800CW related adverse events not to be expected from Dinutuximab-alone infusion, Tumor to background ratio (TBR) of at least 2.0 ex vivo and sufficient for detection during surgery. TBR is established by dividing the mean fluorescence signal of the tumor by the mean fluorescence signal of the background. Background is determined by fluorescence intensity in healthy kidney, liver and surrounding background tissue.
Detailed description
Pharmacokinetics of anti-GD2-800CW; blood samples will be taken at t=0 (just before infusion), t=8h (directly after infusion), t=24h (after infusion), t=72h (after infusion), t=96h (immediately before surgery), t=120h (24h after surgery), t=144h (48h after surgery) and t=192h (4 days after surgery)., The sensitivity and specificity of anti-GD2-800CW to detect GD2-expressing, vital tumor cells. Pathologic status of removed fluorescent tissue and of removed fluorescent tissue will be compared to fluorescent status., Clinical visibility: score of ≥ 4.0 on a Likert scale of 1-5 based on the judgement of three surgeons. They will grade the intra-operative visibility of the fluorescence and whether a clear distinction can be made on eyesight between tumor and surrounding tissue based on fluorescence.
Interventions
DRUGAnti-GD2-800CW
Sponsors
Prinses Maxima Centrum voor Kinderoncologie B.V.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-GD2-800CW related adverse events not to be expected from Dinutuximab-alone infusion, Tumor to background ratio (TBR) of at least 2.0 ex vivo and sufficient for detection during surgery. TBR is established by dividing the mean fluorescence signal of the tumor by the mean fluorescence signal of the background. Background is determined by fluorescence intensity in healthy kidney, liver and surrounding background tissue. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of anti-GD2-800CW; blood samples will be taken at t=0 (just before infusion), t=8h (directly after infusion), t=24h (after infusion), t=72h (after infusion), t=96h (immediately before surgery), t=120h (24h after surgery), t=144h (48h after surgery) and t=192h (4 days after surgery)., The sensitivity and specificity of anti-GD2-800CW to detect GD2-expressing, vital tumor cells. Pathologic status of removed fluorescent tissue and of removed fluorescent tissue will be compared to fluorescent status., Clinical visibility: score of ≥ 4.0 on a Likert scale of 1-5 based on the judgement of three surgeons. They will grade the intra-operative visibility of the fluorescence and whether a clear distinction can be made on eyesight between tumor and surrounding tissue based on fluorescence. | — |
Countries
Netherlands
Outcome results
None listed