AuthorisedTherapeutic exploratory (Phase II)Interventional

Individualized Intrathecal Chemotherapy Based on Measurement of Brain Fluid Clearance in Pediatric Patients

Children and young people with blood cancers such as leukaemia or lymphoma often need chemotherapy injected directly into the fluid around the spine and brain. This helps clear any hidden cancer cells. However, everyone's body clears this fluid at a different speed. If fluid drains too slowly, medicines can cause side effects. If it drains too quickly, the treatment may not work as well. This study tests whether a safe imaging dye called gadobutrol can accurately show how quickly brain fluid clears into the blood. Patients receive the dye alongside their regular care, followed by standard blood tests and health checks. Doctors will check for short-term symptoms like headaches and monitor memory and energy levels for up to two years. The ultimate goal is to help doctors personalise chemotherapy doses for each individual patient.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Oslo University Hospital HF

Enrolment target

Start

03 Jul 2026

Acute lymphoblastic leukemia and lymphoma

What is this study about?

Acute lymphoblastic leukaemia and lymphoma are types of blood cancer that can travel into the central nervous system. To treat or prevent this, doctors regularly give chemotherapy directly into the fluid surrounding the spinal cord and brain. This is called intrathecal chemotherapy.

Currently, most young patients receive similar doses based mainly on their age or body size. However, the fluid around the brain and spine flows and clears at different speeds from person to person. If fluid clears too slowly, medicines might build up and cause unwanted side effects. If it clears too quickly, the medicine may not stay long enough to clear cancer cells properly.

In this study, researchers are testing a tracer dye called gadobutrol. By checking how quickly this dye moves from the spinal fluid into the blood, doctors hope to calculate each child's personal fluid clearance rate. They will also look closely at any side effects, everyday energy levels, and learning and memory skills over a two-year period.

By understanding how fluid moves through the brain and spine, doctors hope to design personalised chemotherapy doses in the future. This could make treatments kinder and more effective for children with blood cancers across the NHS.

Key takeaways

Tests how quickly fluid drains from the brain and spine in young blood cancer patients.
Uses a well-known tracer dye (gadobutrol) to measure fluid clearance in the blood.
Aims to help doctors tailor future spinal chemotherapy doses to each child's body.
Includes checks on side effects, energy levels, and memory for up to two years.
Taking part is optional and works alongside normal NHS cancer care.

Who may be eligible?

This study is designed for children and young people diagnosed with acute lymphoblastic leukaemia (ALL) or lymphoma who need chemotherapy into their spinal fluid as part of their routine cancer care.

Both boys and girls of any age receiving this treatment may be considered. Because this study involves tracking fluid movement, patients must be well enough to receive the tracer dye and have blood samples taken afterwards.

Your child's hospital care team can confirm whether this study fits alongside their planned cancer treatment and overall health needs.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Diagnosed with acute lymphoblastic leukaemia (ALL) or lymphoma
Due to receive chemotherapy injections into the spinal fluid
Able to have blood samples taken at scheduled times
Able to take part in follow-up memory and tiredness questionnaires

Answer every question to see your result.

What does participation involve?

If your child joins the study, they will receive the tracer dye (gadobutrol) into their spinal fluid around the same time as their planned chemotherapy procedure. Staff will observe your child closely for at least 30 minutes afterwards. Over the next few hours and days, small blood samples will be taken to measure how quickly the dye moves into the bloodstream.

Doctors will check for any short-term symptoms, such as headache or nausea, over the first seven days. Follow-up visits will fit around your child's normal hospital appointments and include simple questionnaires to measure tiredness and thinking skills at three months and two years. In total, study follow-up lasts up to two years.

Potential risks and benefits

Taking part may not directly improve your child's health, but it could help doctors tailor treatments more safely for children with blood cancer in the future. Gadobutrol is widely used in medical imaging, but possible side effects include temporary headaches, dizziness, feeling sick, or mild bruising where blood samples are taken. Serious reactions are rare, and the care team will monitor your child very closely. Participation is entirely voluntary, and you can withdraw at any time without affecting your child's standard NHS treatment.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

What is gadobutrol?

It is a medical tracer dye commonly used in routine MRI scans to help doctors see fluids and tissues clearly.

Will taking part delay my child's cancer treatment?

No. The study is designed to run alongside your child's planned cancer care and will not delay their treatment.

Are there extra procedures involved?

The dye is given during a spinal procedure your child is already having. Extra steps mainly involve a few blood samples and short questionnaires.

What happens if my child gets a headache or feels sick?

The medical team monitors your child closely and can provide standard medicines to quickly relieve symptoms like nausea or pain.

Can we change our minds after joining?

Yes. You can leave the study at any time, and your child will continue to receive the best standard care from their doctors.