Evaluating brain changes in children with acute lymphoblastic leukemia during chemotherapy
Clinical Study of the Therapy Neurotoxicity Using Quantitative Assessment of the Brain Structures and Functions by MRI, EEG and Evoked Potentials in Patients With Acute Lymphoblastic Leukemia Over 6 Years Old
This study is trying to see how chemotherapy affects the brains of children with leukemia, specifically looking at changes caused by a common drug called methotrexate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology Academic / other |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 1 site (Moscow) |
| Trial ID | NCT04767152 on ClinicalTrials.gov |
What this trial studies
This study assesses the neurological effects of chemotherapy on children aged 6 to 18 diagnosed with acute lymphoblastic leukemia. It focuses on the impact of methotrexate, a common chemotherapy drug, which can lead to neurotoxicity and leukoencephalopathy. Using quantitative MRI, the study aims to non-invasively evaluate brain changes that may occur during treatment, even in the absence of clinical symptoms. This research addresses a gap in the literature regarding the neurological assessment of pediatric patients undergoing chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 18 years who are currently receiving chemotherapy for acute lymphoblastic leukemia.
Not a fit: Patients outside the age range of 6 to 18 years or those unable to undergo MRI without general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of neurotoxicity in children undergoing treatment for acute lymphoblastic leukemia.
How similar studies have performed: While there is existing literature on the neurological effects of chemotherapy, this specific quantitative MRI approach in children is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients from 6 to 18 years old 2. diagnosis of acute lymphoblastic leukemia during chemotherapy Exclusion Criteria: 1. patients less then 6, and older then 18 years old 2. patients who cannot perform the study MRI without general anesthesia 3. Refusal to sign informed consent. 4. The presence of absolute contraindications to MRI studies. 5. Extremely serious condition of the patient.
Where this trial is running
Moscow
- Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology — Moscow, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Nataliia f Kriventsova
- Email: nataliya.krivencova@fccho-moscow.ru
- Phone: +7 (495)2876570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.