Clinical trial · Interventional
Evaluation of Brain Changes in ALL Patients on Therapy
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
NCT04767152CI-TRIAL-00070903unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- percentage of the macromolecular proton fraction (MPF) in brain tissue.
- timeFrame
- Before the start of therapy
- description
- macromolecular proton fraction (MPF) in brain tissue.
- measure
- percentage of the macromolecular proton fraction (MPF) in brain tissue.
- timeFrame
- 36 ± 3 days after the start of the therapy..
- description
- macromolecular proton fraction (MPF) in brain tissue.
- measure
- percentage of the macromolecular proton fraction (MPF) in brain tissue.
- timeFrame
- ap to 1 week After completing three courses of consolidation chemotherapy.
- description
- macromolecular proton fraction (MPF) in brain tissue.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.