Individualized Intrathecal Chemotherapy Based on Measurement of Brain Fluid Clearance in Pediatric Patients
Key facts
- Where
- Oslo, NorvégiaSee the site
- Phase
- 2. fázis
Where in Norvégia
- Oslo University Hospital HFOslo, NorvégiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital HF
- Trial code
- EU 2025-522453-20-00
- Record updated
- 2026. augusztus 4.
- Original description
Investigate/estimate brain fluid clearance (BFC) at the individual level in children aged 12-17 years undergoing clinically indicated intrathecal chemotherapy (methotrexate, and where applicable cytarabine) for blood or lymph cancer.Read full original descriptionShow less
Investigate/estimate brain fluid clearance (BFC) at the individual level in children aged 12-17 years undergoing clinically indicated intrathecal chemotherapy (methotrexate, and where applicable cytarabine) for blood or lymph cancer.
Inclusion: Age. Participant must be in the age range 12 to 17 years at the time of signing the informed consent; Type of Participant and Disease Characteristics. Individuals undergoing intrathecal chemotherapy with MTX for blood or lymph cancer and being treated at Oslo University Hospital; Weight. Body weight is above 50 kg; Sex and Contraceptive/Barrier Requirements. Both male and female. WOCBP may be included only if they meet protocol pregnancy-testing requirements, have a confirmed menstrual period, have a negative highly sensitive urine or serum pregnancy test before inclusion/intervention, and use highly effective contraception where applicable from inclusion through Day 7 safety follow-up. WOCBP means a post-menarche female participant who is not permanently sterile and not post-menopausal; Informed Consent. Documented informed consent/assent must be obtained before any study-specific procedure. Ages 12-15: consent from person(s) with parental responsibility plus age-adapted information and assent/participation according to maturity. Ages 16-17: participant informed consent plus consent from person(s) with parental responsibility. If a participant reaches 18 years before further protocol-defined procedures, express adult informed consent must be obtained.
Exclusion: Medical condition. Renal failure; Medical condition. Hypersensitivity/Allergy to contrast agents; Medical condition. Lowered seizure threshold; Other. Pregnancy or breast feeding.