Acute LeukemiaNCT04767152
Evaluation of Brain Changes in ALL Patients on Therapy
A study testing MRI in people with Acute Leukemia, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- MRI
- How many people
- 110 participants
- Where
- 1 siteRussia
- Study dates
- 16 Feb 2021to 21 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients from 6 to 18 years old
- diagnosis of acute lymphoblastic leukemia during chemotherapy
Who cannot join
- patients less then 6, and older then 18 years old
- patients who cannot perform the study MRI without general anesthesia
- Refusal to sign informed consent.
- The presence of absolute contraindications to MRI studies.
- Extremely serious condition of the patient.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology
Moscow, 117997
Dmitry Balashov, MD, PhD, +7(495)287-6570 ext. 6534, bala8@yandex.ru
Michael Maschan, Professor, mmaschan@yandex.ru
About this study
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
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.
Read the detailed 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.
- Conditions
- Acute Leukemia
- Being tested
- MRI
- Keywords
- Quantitative MRI, acute lymphoblastic leukemia, neurotoxity, children
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of the macromolecular proton fraction (MPF) in brain tissue.
macromolecular proton fraction (MPF) in brain tissue.
Measured: Before the start of therapy
percentage of the macromolecular proton fraction (MPF) in brain tissue.
macromolecular proton fraction (MPF) in brain tissue.
Measured: 36 ± 3 days after the start of the therapy..
percentage of the macromolecular proton fraction (MPF) in brain tissue.
macromolecular proton fraction (MPF) in brain tissue.
Measured: ap to 1 week After completing three courses of consolidation chemotherapy.
percentage of the macromolecular proton fraction (MPF) in brain tissue.
macromolecular proton fraction (MPF) in brain tissue.
Measured: ap to 1 week After confirmation of remission status, optionally provided.
Secondary outcomes (4)
T1 maping
T1 mapping (ms) is a magnetic resonance imaging technique used to calculate at 4 time points
Measured: 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
apparent diffusion coefficient
value of apparent diffusion coefficient in mm2/s calculated at 4 time points
Measured: 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
percentage of the water myelin fraction
water myelin fraction calculated at 4 time points
Measured: 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
value of the cerebral blood flow
cerebral blood flow (CBF) (ml/100g/min) in brain tissue. calculated at 4 time points
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start16 Feb 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion21 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767152
- Sponsor's protocol ID
- NCPHOI-2019-07
- Status last verified
- Oct 2023
- First submitted
- 16 Feb 2021
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04767152
- Acronym / sponsor ID
- NCPHOI-2019-07
- Conditions
- Acute Leukemia
- Keywords
- Quantitative MRI, acute lymphoblastic leukemia, neurotoxity, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 21 Jan 2026 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients from 6 to 18 years old
- diagnosis of acute lymphoblastic leukemia during chemotherapy
Key exclusion criteria (5 listed)
- patients less then 6, and older then 18 years old
- patients who cannot perform the study MRI without general anesthesia
- Refusal to sign informed consent.
- The presence of absolute contraindications to MRI studies.
- Extremely serious condition of the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIThe 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. | Diagnostic test | – |
Primary outcome
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Time frame: Before the start of therapy
macromolecular proton fraction (MPF) in brain tissue.
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Time frame: 36 ± 3 days after the start of the therapy..
macromolecular proton fraction (MPF) in brain tissue.
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Time frame: ap to 1 week After completing three courses of consolidation chemotherapy.
macromolecular proton fraction (MPF) in brain tissue.
percentage of the macromolecular proton fraction (MPF) in brain tissue.
Time frame: ap to 1 week After confirmation of remission status, optionally provided.
macromolecular proton fraction (MPF) in brain tissue.
4 secondary outcomes
T1 maping
Time frame: 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
apparent diffusion coefficient
Time frame: 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
percentage of the water myelin fraction
Time frame: 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
value of the cerebral blood flow
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Acute Leukemia, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nataliia f Kriventsova (+7 (495)2876570 ext. 4508, nataliya.krivencova@fccho-moscow.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of the macromolecular proton fraction (MPF) in brain tissue. (time frame: Before the start of therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.