Neuroblastoma
Conditions
Brief summary
Response by the Revised International Neuroblastoma Response Criteria (INRC) at 1 month after the completion of therapy
Detailed description
Response based on 68Ga-DOTATOC PET/CT imaging at 1 and 4 months after completion of therapy in measurable target lesions, Response based on 123I-mIBG SPECT/CT imaging (when available) at 1 and 4 months after completion of therapy in measurable target lesions, Response by the Revised INRC criteria at 4 months after the completion of therapy, Progression free survival (PFS), Overall survival (OS), Hematological and renal toxicity according to CTCAE 5.0
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response by the Revised International Neuroblastoma Response Criteria (INRC) at 1 month after the completion of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Response based on 68Ga-DOTATOC PET/CT imaging at 1 and 4 months after completion of therapy in measurable target lesions, Response based on 123I-mIBG SPECT/CT imaging (when available) at 1 and 4 months after completion of therapy in measurable target lesions, Response by the Revised INRC criteria at 4 months after the completion of therapy, Progression free survival (PFS), Overall survival (OS), Hematological and renal toxicity according to CTCAE 5.0 | — |
Countries
Denmark, Lithuania, Netherlands, Norway, Spain, Sweden