2025-522453-20-00Not yet recruitingPhase 2
Individualized Intrathecal Chemotherapy Based on Measurement of Brain Fluid Clearance in Pediatric Patients
Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 13 Mar 2026
- Start date
- 1 Sept 2026
- Lead sponsor
- Oslo University Hospital HF
- EU CT number
- 2025-522453-20-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Medical condition. Renal failure
- Medical condition. Hypersensitivity/Allergy to contrast agents
- Medical condition. Lowered seizure threshold
Other
- Other. Pregnancy or breast feeding.
Who the study is looking for
- 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.
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital HF | Oslo | Norway | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.