Acute lymphoblastic leukemia and lymphoma
Conditions
Brief summary
Exploratory model-derived BFC indices [absorption half-life (t½abs), time to maximal blood concentration (Tmax) of gadobutrol and maximum concentration (Cmax)] from the predefined gadobutrol popPK model using actual dose and sampling times.
Detailed description
Solicited AEs/AESIs Day 0-7, including headache, nausea, dizziness and other predefined symptoms; SAE/SUSAR occurrence; 30-minute post-dose observation findings., Mental Fatigue Scale score at 3 months., Change in neuropsychological test/questionnaire measures from baseline to 3 months and 2 years.
Interventions
DRUGGadobutrol 1.0 mmol/mL solution for injection
Sponsors
Oslo University Hospital HF
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exploratory model-derived BFC indices [absorption half-life (t½abs), time to maximal blood concentration (Tmax) of gadobutrol and maximum concentration (Cmax)] from the predefined gadobutrol popPK model using actual dose and sampling times. | — |
Secondary
| Measure | Time frame |
|---|---|
| Solicited AEs/AESIs Day 0-7, including headache, nausea, dizziness and other predefined symptoms; SAE/SUSAR occurrence; 30-minute post-dose observation findings., Mental Fatigue Scale score at 3 months., Change in neuropsychological test/questionnaire measures from baseline to 3 months and 2 years. | — |
Outcome results
None listed