somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomas
Conditions
Brief summary
Target organ (e.g. kidney and bone marrow) absorbed radiation doses in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort., The incidence of adverse events (AEs) and laboratory toxicities after the 1st Lutathera administration in adolescents with SSTR-positive GEPNETs and PPGLs as a pooled cohort
Detailed description
The incidence of adverse events (AEs) and laboratory toxicities until 6 months after the last Lutathera dose (short-term follow-up) in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort., The incidence of adverse events (AEs) and laboratory abnormalities during the long term follow-up of 5 years after the last Lutathera dose in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort., Calculated organ absorbed doses and PK parameters based on imaging/blood radioactivity concentration data from adolescent patients with SSTR-positive GEP-NETs and PPGLs as a pooled cohort compared to the predicted distribution /organ absorbed doses
Interventions
Sponsors
Advanced Accelerator Applications
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target organ (e.g. kidney and bone marrow) absorbed radiation doses in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort., The incidence of adverse events (AEs) and laboratory toxicities after the 1st Lutathera administration in adolescents with SSTR-positive GEPNETs and PPGLs as a pooled cohort | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (AEs) and laboratory toxicities until 6 months after the last Lutathera dose (short-term follow-up) in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort., The incidence of adverse events (AEs) and laboratory abnormalities during the long term follow-up of 5 years after the last Lutathera dose in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort., Calculated organ absorbed doses and PK parameters based on imaging/blood radioactivity concentration data from adolescent patients with SSTR-positive GEP-NETs and PPGLs as a pooled cohort compared to the predicted distribution /organ absorbed doses | — |
Countries
France, Poland, Spain
Outcome results
None listed