Evaluation of Brain Changes in ALL Patients on Therapy

Acute Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04767152
• Other study ID #: NCPHOI-2019-07
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: January 21, 2026

Study information

• Verified date: October 2023
• Source: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Contact: Nataliia f Kriventsova
• Phone: +7 (495)2876570
• Email: nataliya.krivencova[@]fccho-moscow.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is aimed at assessing changes in the brain of patients from 6 to 18 years old with a diagnosis of acute lymphoblastic leukemia during chemotherapy.

Description:

Children with acute lymphoblastic leukemia receive long-term combined chemotherapy treatment, one of the main part of this treatment is methotrexate. Methotrexate can cause acute, subacute, and long-term neurotoxicity. Clinical symptoms of neurotoxicity, such as seizures, aphasia, are often associated with leukoencephalopathy. However, leukoencephalopathy may develop asymptomatically in children receiving methotrexate. The effect of chemotherapy on the neurological status of patients is widely covered in the literature. There are very few studies devoted to the quantitative assessment of MRI parameters, especially in children. MRI is a non-invasive method that does not harm the patient and can be used to assess absolutely all structures of the brain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 21, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Leukemia
• Leukemia

Intervention

Diagnostic Test:
• MRI
The quantitative assessment of MRI parameters, The macromolecular proton fraction (MPF) (%) in brain tissue. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. After completing three courses of consolidation chemotherapy. Point 4. After confirmation of remission status, optionally provided.

Locations

Country	Name	City	State
Russian Federation	Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of the macromolecular proton fraction (MPF) in brain tissue.	macromolecular proton fraction (MPF) in brain tissue.	Before the start of therapy
Primary	percentage of the macromolecular proton fraction (MPF) in brain tissue.	macromolecular proton fraction (MPF) in brain tissue.	36 ± 3 days after the start of the therapy..
Primary	percentage of the macromolecular proton fraction (MPF) in brain tissue.	macromolecular proton fraction (MPF) in brain tissue.	ap to 1 week After completing three courses of consolidation chemotherapy.
Primary	percentage of the macromolecular proton fraction (MPF) in brain tissue.	macromolecular proton fraction (MPF) in brain tissue.	ap to 1 week After confirmation of remission status, optionally provided.
Secondary	T1 maping	T1 mapping (ms) is a magnetic resonance imaging technique used to calculate at 4 time points	Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
Secondary	apparent diffusion coefficient	value of apparent diffusion coefficient in mm2/s calculated at 4 time points	Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
Secondary	percentage of the water myelin fraction	water myelin fraction calculated at 4 time points	Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year
Secondary	value of the cerebral blood flow	cerebral blood flow (CBF) (ml/100g/min) in brain tissue. calculated at 4 time points	Point 1. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. 4 mounths ± 1 week after the start of the therapy. Point 4. through study completion, an average of 2 year