Clinical trial NCT04767165: Quantitative MRI of Bone Marrow in Patients With Acute Lymphoblastic Leukemia
Official title: Clinical Pilot Study of Quantitative MRI Assessment of Bone Marrow in Patients With Acute Lymphoblastic Leukemia and Patients Without Hematopoietic Disorders, From 6 to 18 Years Old
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Leukemia
Keywords: Quantitative MRI
acute lymphoblastic leukemia
bone marrow
children
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The study is aimed at assessing changes in the bone marrow of patients from 6 to 18 years old with a diagnosis of acute lymphoblastic leukemia during chemotherapy. Patients of the same age without hematological diseases will be recruited as a control group.

Detailed description: The ratio of fat to water in the bone marrow depends on the cellularity of the bone marrow. In addition to the water/fat ratio in bone marrow there are also other parameters for quantitative MRI assessment. These include the apparent diffusion coefficient (ACD), the T1 relaxation time, mapping of the macromolecular proton fraction. The undoubted advantage of MRI is its non-invasiveness and the ability to assess any localization of the bone marrow.

MRI may become a new non-invasive method for assessing the ratio of fat to cells in the bone marrow in children with hematological malignancies, which can help in making a diagnosis and monitoring the response to therapy.

Eligibility criteria: Inclusion Criteria:

1. patients from 6 to 18 years old
2. diagnosis of acute lymphoblastic leukemia during chemotherapy
3. patients of the same age without hematological diseases

Exclusion Criteria:

1. patients less then 6, and older then 18 years old
2. patients who cannot perform the study MRI without general anesthesia

Primary outcomes:
measure: Dynamics of Bone marrow fat fraction
timeFrame: Point 1. Before the start of therapy - the starting point.
measure: Dynamics of Bone marrow fat fraction
timeFrame: Point 2. 15 ± 3 days after the start of the therapy.
measure: Dynamics of Bone marrow fat fraction
timeFrame: Point 3. 36 ± 3 days after the start of the therapy.
measure: Dynamics of Bone marrow fat fraction
timeFrame: Point 4. through study completion, an average of 2 year
Secondary outcomes:
measure: T1 maping (ms)
timeFrame: Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year
measure: apparent diffusion coefficient (mm2/s)
timeFrame: Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year
measure: bone marrow fat fraction (FF) by spectroscopy (%)
timeFrame: Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year
measure: The macromolecular proton fraction (MPF)
timeFrame: Point 1. Before the start of therapy - the starting point. Point 2. 15 ± 3 days after the start of the therapy. Point 3. 36 ± 3 days after the start of the therapy. Point 4. through study completion, an average of 2 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Study officials:
References: