Not yet recruiting

Brain Fluid Clearance Guided Intrathecal Chemotherapy with Gadobutrol in Adolescents aged 12-17 with Acute Lymphoblastic Leukemia and Lymphoma

Registered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves children aged 12‑17 years who have Acute lymphoblastic leukemia and lymphoma, cancers that affect the blood or lymph system. These patients receive intrathecal chemotherapy, which means the chemotherapy drugs are given directly into the fluid that surrounds the spinal cord. The usual medicines used for this purpose are methotrexate and, when needed, cytarabine. In addition, a small amount of the contrast agent gadobutrol will be injected into the same fluid to measure how quickly the brain’s fluid is cleared, a process referred to as brain fluid clearance. The purpose of the study is to investigate individual brain fluid clearance in children receiving intrathecal chemotherapy.

After the gadobutrol injection, blood samples will be taken at several time points to see how the substance moves through the body, and the children will continue their regular chemotherapy schedule. Participants will be observed for any immediate reactions for about half an hour after the injection and will be asked about common symptoms such as headache, nausea, or dizziness during the first week. Additional follow‑up visits will include simple questionnaires that measure mental fatigue and more detailed tests of thinking and memory at three months, and again at two years, to check for any changes in brain function. All procedures are designed to be as safe and comfortable as possible while gathering information that could help tailor future treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessments
After joining the study, provide informed consent and complete initial paperwork.
Baseline evaluations include a medical history review, neuropsychological testing, and a mental fatigue scale questionnaire.
Step 2
Gadobutrol administration for brain fluid clearance measurement
Receive a single intrathecal injection of gadobutrol 60 mg (solution for injection).
The injection is given into the spinal fluid to allow measurement of brain fluid clearance.
Blood samples are drawn at several time points after the injection to determine absorption half‑life (t½abs), time to maximal blood concentration (tmax), and maximum concentration (cmax).
A 30‑minute observation period follows the injection to monitor for immediate reactions.
Step 3
Intrathecal chemotherapy administration
Receive intrathecal chemotherapy as clinically indicated for acute lymphoblastic leukemia or lymphoma.
The primary drug is methotrexate, given by intrathecal injection according to the treating physician’s standard dosing schedule.
If required, cytarabine may also be administered intrathecally following the same schedule.
Chemotherapy doses are typically given every 3 to 4 weeks, aligned with the patient’s overall treatment plan.
Step 4
Monitoring for adverse events
After each intrathecal injection, observe for at least 30 minutes for any immediate symptoms.
Record any solicited adverse events such as headache, nausea, dizziness, or other predefined symptoms during days 0 to 7 after the injection.
Serious adverse events or unexpected safety issues are documented throughout the study period.
Step 5
Follow‑up assessments
At 3 months after the initial gadobutrol measurement, complete the mental fatigue scale again.
Repeat neuropsychological tests at 3 months and again at 2 years to evaluate changes from baseline.
Step 6
Study completion and data analysis
After the final follow‑up visit, all collected data are reviewed and analyzed to assess brain fluid clearance and treatment outcomes.
No further study procedures are required after data collection is finished.

Who can join the trial?

5 criteria

Age: You must be between 12 and 17 years old when you sign the consent form.
Type of treatment: You need to be receiving a special type of chemotherapy called intrathecal chemotherapy (medicine given directly into the fluid around the spinal cord) that includes the drug methotrexate (MTX) for a blood or lymph cancer, and you must be treated at Oslo University Hospital.
Weight: You must weigh more than 50 kilograms (about 110 pounds).
Sex and pregnancy rules: Both boys and girls can join. Girls who could become pregnant (called women of child‑bearing potential) must have a confirmed menstrual period, take a highly sensitive pregnancy test that is negative, and use a reliable form of birth control from the start of the study through the first 7 days of safety follow‑up.
Informed consent: A signed consent form is required before any study steps. If you are 12‑15 years old, a parent or guardian must also sign and you must give your own agreement (assent). If you are 16‑17 years old, you sign the consent and a parent or guardian also signs. If you turn 18 before later study procedures, an adult consent form must be signed.

Who cannot join the trial?

4 criteria

Having renal failure (the kidneys are not working well enough).
Being allergic or very sensitive to contrast agents (the special dye used in some scans).
Having a lowered seizure threshold (meaning you are more likely to have a seizure).
Being pregnant or breastfeeding (currently having a baby in the womb or feeding a baby with breast milk).

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Gadobutrol
is a special dye that doctors inject into the fluid surrounding the brain and spinal cord. In this study it is used only as a test to see how quickly that fluid moves and clears, which helps personalize the chemotherapy dose for each child.
Methotrexate
is a chemotherapy medicine that is given directly into the spinal fluid (intrathecally). It is part of the regular treatment for blood or lymph cancers in the children taking part in the trial, helping to kill cancer cells that may be in the central nervous system.
Cytarabine
is another chemotherapy drug that can be given intrathecally when needed. It works similarly to methotrexate by targeting cancer cells in the brain and spinal fluid, and is used in some children as part of their standard cancer therapy.

Gadobutrol

What is already known about the treatment

Gadobutrol 1.0 mmol/mL solution for injection - Gadobutrol is given as a sterile liquid that is injected directly into the spinal fluid (intrathecal injection). It is an approved gadolinium‑based contrast agent and is listed in the ATC classification V08CA09. The main use is to make brain and spinal cord images clearer during MRI scans, especially when checking for cancers such as acute lymphoblastic leukemia and lymphoma that can involve the nervous system. It works by shortening the relaxation time of nearby water molecules, causing the scanned area to appear brighter, and it belongs to the pharmacological class of magnetic resonance imaging contrast media.

Investigated diseases

Acute lymphoblastic leukemia
a fast‑growing cancer of the white blood cells that starts in the bone marrow and spreads into the blood. It begins when immature lymphocytes multiply uncontrollably, crowding out normal blood cells. As the disease advances, patients may develop anemia, bruising, and infections because healthy blood cells are reduced. The abnormal cells can travel to other organs, such as the central nervous system, leading to further complications. The disease typically progresses quickly, prompting prompt medical attention.
Lymphoma
a group of cancers that arise from lymphocytes, the cells of the immune system, forming solid tumors in lymph nodes or other tissues. It starts when a single lymphocyte begins to grow abnormally and creates a mass that can enlarge over time. The disease may spread locally to nearby lymph nodes and later to distant organs through the bloodstream or lymphatic channels. Symptoms often develop as the tumor grows, causing swelling, pain, or discomfort in the affected area. Without intervention, the tumor can continue to increase in size and involve additional body sites.