Aplastic AnemiaNCT04761965
Quantitative MRI of Bone Marrow Fat Fraction in Patients With Trepanobiopsy
A study testing Bone marrow cellularity by mDixon-quant in people with Aplastic Anemia and Aplastic Anemia Idiopathic, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
Trial summary
The study is aimed to find correlation between the assessment of cellularity according to trepanobiopsy data and the results of measuring MRI parameters. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Aplastic Anemia, Aplastic Anemia Idiopathic
- What is being tested?
- Bone marrow cellularity by mDixon-quant
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 16 Feb 2021to 1 Jan 2024
- 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
- presence of indications for performing trepanobiopsy:
- aplastic anemia
- chronic myeloproliferative disease
- reactive changes in hematopoiesis
Who cannot join
- Refusal to sign an informed consent to participate in a clinical trial
- Presence of contraindications for MRI examination
- Extremely serious condition of the patient at the time of inclusion in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Moscow, Samory-Mashela,1, 11198
Lena f Smirnova, lena.smirnova@fccho-moscow.ru
About this study
Official title: Clinical Study of the Sensitivity and Specificity of the Quantitative Assessment of Bone Marrow Cellularity by MRI in Comparison With Trepanobiopsies in Patients With Diseases of the Hematopoietic System
The study is aimed to find correlation between the assessment of cellularity according to trepanobiopsy data and the results of measuring MRI parameters.
Read the 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 cellularity of the bone marrow in children with oncohematological diseases.
- Conditions
- Aplastic Anemia, Aplastic Anemia Idiopathic
- Being tested
- Bone marrow cellularity by mDixon-quant
- Keywords
- Quantitative MRI, trepanobiopsy, Aplastic Anemia Idiopathic, children
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow cellularity by mDixon-quantDiagnostic test
if trepanobiopsy was performed during the diagnosis, then comparison with MRI Bone marrow cellularity by mDixon-quant
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between Bone marrow cellularity by mDixon-quant and trepanobiopsy.
Determination of bone marrow cellularity before starting therapy for the underlying disease. Cellularity according to trepanobiopsy data is the ratio of stromal and hematopoietic cells to fat cells in the bone marrow. Cellularity according to MRI - the ratio of water and fat in the bone marrow using the mDixom Quant.
Measured: Before the start of treatment
Secondary outcomes (4)
T1 maping
T1 mapping (ms) is a magnetic resonance imaging technique used to calculate the T1 time
Measured: Before the start of treatment
apparent diffusion coefficient
value of apparent diffusion coefficient in mm2/s
Measured: Before the start of treatment
Percentage of the macromolecular proton fraction (MPF)
Percentage of the macromolecular proton fraction (MPF)
Measured: Before the start of treatment
Percentage of the bone marrow fat fraction
Percentage of the bone marrow fat fraction (FF) by spectroscopy
Measured: Before the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start16 Feb 2021
- Primary completion26 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aplastic AnemiaStudies 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
- 150 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
- NCT04761965
- Sponsor's protocol ID
- NCPHOI-2019-06
- Status last verified
- Mar 2023
- First submitted
- 15 Feb 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Sensitivity and Specificity of the Quantitative Assessment of Bone Marrow Cellularity by MRI in Comparison With Trepanobiopsies in Patients With Diseases of the Hematopoietic System
- ClinicalTrials.gov ID
- NCT04761965
- Acronym / sponsor ID
- NCPHOI-2019-06
- Conditions
- Aplastic Anemia, Aplastic Anemia Idiopathic
- Keywords
- Quantitative MRI, trepanobiopsy, Aplastic Anemia Idiopathic, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 26 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 21 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 to find correlation between the assessment of cellularity according to trepanobiopsy data and the results of measuring MRI parameters.
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 cellularity of the bone marrow in children with oncohematological diseases.
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 (4 listed)
- aplastic anemia
- chronic myeloproliferative disease
- reactive changes in hematopoiesis
Key exclusion criteria (3 listed)
- Refusal to sign an informed consent to participate in a clinical trial
- Presence of contraindications for MRI examination
- Extremely serious condition of the patient at the time of inclusion in the study.
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 |
|---|---|---|
| Bone marrow cellularity by mDixon-quantif trepanobiopsy was performed during the diagnosis, then comparison with MRI Bone marrow cellularity by mDixon-quant | Diagnostic test | – |
Primary outcome
correlation between Bone marrow cellularity by mDixon-quant and trepanobiopsy.
Time frame: Before the start of treatment
Determination of bone marrow cellularity before starting therapy for the underlying disease. Cellularity according to trepanobiopsy data is the ratio of stromal and hematopoietic cells to fat cells in the bone marrow. Cellularity according to MRI - the ratio of water and fat in the bone marrow using the mDixom Quant.
4 secondary outcomes
T1 maping
Time frame: Before the start of treatment
apparent diffusion coefficient
Time frame: Before the start of treatment
Percentage of the macromolecular proton fraction (MPF)
Time frame: Before the start of treatment
Percentage of the bone marrow fat fraction
Time frame: Before the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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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 Bone marrow cellularity by mDixon-quant in people with Aplastic Anemia and Aplastic Anemia Idiopathic, 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 4 inclusion and 3 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 8 Mar 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 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?
correlation between Bone marrow cellularity by mDixon-quant and trepanobiopsy. (time frame: Before the start of treatment). 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 8 Mar 2023.