Diffusion MRINCT06703138
Role of Diffusion MRI in Differentiation of Various Bone Marrow Lesions
An observational study of Diffusion MRI and Bone Marrow Disease, run by Assiut University.
Trial summary
Bone marrow lesions are common, and imaging findings are associated with various aetiologies, as compared to conventional radiography and computed tomography (CT), MRI is a better non-invasive imaging modality to evaluate vertebral bone marrow, due to better soft-tissue contrast, so the aim of our study is the use of… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Diffusion MRI, Bone Marrow Disease
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- Adult
Study population: - All adult patients with various vertebral bone marrow lesions.
Who may be able to join
- All adult patients with vertebral lesions Clinically suspected or diagnosed by other modalities as X-ray or CT were included in the study.
Who cannot join
- Patients with metallic prosthesis which are not MRI compatible .
- patients with previous Vertebral surgery.
- patients with Vertebral Congenital anomalies
- Patients refused the examination.
- Patients who suffer from claustrophobia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of MRI Diffusion in Differentiation Between Various Vertebral Bone Marrow Pathological Lesions. .
Bone marrow lesions are common, and imaging findings are associated with various aetiologies, as compared to conventional radiography and computed tomography (CT), MRI is a better non-invasive imaging modality to evaluate vertebral bone marrow, due to better soft-tissue contrast, so the aim of our study is the use of MRI diffusion in differentiating various vertebral bone marrow pathological lesions.
Read the detailed description
Bone marrow lesions are common, and imaging findings are associated with various aetiologies, such as degenerative, infectious, traumatic, malignant, metabolic, and haematopoietic .
As compared to conventional radiography and computed tomography (CT), MRI is a better non-invasive imaging modality to evaluate vertebral bone marrow, due to better soft-tissue contrast as well as being non-ionising in nature .
Although conventional MRI is essential for anatomical visualization and lesion detection in bone marrow pathologies ,but it often insufficient in distinguishing different vertebral bone marrow lesions, due to overlapping imaging features and often due to coexistence of bone marrow oedema that can be caused by fractures, infection, and bone marrow hyperplasia, thus reducing the specificity of conventional sequences .
MRI diffusion provides complementary information about tissue microstructure and cellular .it exploits the translational mobility of water molecules to obtain information on the microscopic behaviour of the tissues.
On the other hand, apparent diffusion coefficient (ADC) values provide quantitative measure of Brownian movement with low ADC values implying restricted diffusion and high values being a measure of free diffusion.
Therefore, DWI provides both qualitative and quantitative functional information concerning the microscopic movements of water at the cellular level. The benefits of DWI comprise a small scanning period that allows it to be easily included in the routine imaging protocols .
For example, In healthy bone marrow, water diffusion is relatively unrestricted due to its cellularity and vascularity, while pathologies such as metastatic disease or myelofibrosis typically exhibit restricted diffusion.
Diffusion MRI can also distinguish bone marrow edema like acute injury or inflammation, from infiltrative diseases such as multiple myeloma. Edema typically shows higher ADC values due to the increased water content, whereas infiltrative diseases reduce diffusion, resulting in lower ADC values.
These examples illustrate how MRI diffusion can differentiate various vertebral bone marrow pathological lesions.
- Conditions
- Diffusion MRI, Bone Marrow Disease
- Keywords
- MRI, Bone marrow pathologies
- Medical subject headings
- Bone Marrow Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of MRI diffusion in differentiation between Various Vertebral bone marrow pathological lesions. .
Primary (main):
Establishing correlations between DWI findings and laboratory, clinical or histopathological results.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diffusion MRIStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Hassan Mahmoud Nafadi, Assiut University
- Investigators
- Eman A. Ahmed, Study director, ProfessorShimaa F. Gad, Study director, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703138
- Sponsor's protocol ID
- MRI in bone marrow lesions
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leake RL, Mills MK, Hanrahan CJ. Spinal Marrow Imaging: Clues to Disease. Radiol Clin North Am. 2019 Mar;57(2):359-375. doi: 10.1016/j.rcl.2018.09.008. Epub 2018 Nov 17.
PubMed 30709475Lin S, Ouyang T, Kanekar S. Imaging of Bone Marrow. Hematol Oncol Clin North Am. 2016 Aug;30(4):945-71. doi: 10.1016/j.hoc.2016.03.012.
PubMed 27444005Dietrich O, Geith T, Reiser MF, Baur-Melnyk A. Diffusion imaging of the vertebral bone marrow. NMR Biomed. 2017 Mar;30(3). doi: 10.1002/nbm.3333. Epub 2015 Jun 26.
PubMed 26114411Karampinos DC, Ruschke S, Dieckmeyer M, Diefenbach M, Franz D, Gersing AS, Krug R, Baum T. Quantitative MRI and spectroscopy of bone marrow. J Magn Reson Imaging. 2018 Feb;47(2):332-353. doi: 10.1002/jmri.25769. Epub 2017 Jun 1.
PubMed 28570033Padhani AR, Koh DM. Diffusion MR imaging for monitoring of treatment response. Magn Reson Imaging Clin N Am. 2011 Feb;19(1):181-209. doi: 10.1016/j.mric.2010.10.004.
PubMed 21129641
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of MRI Diffusion in Differentiation Between Various Vertebral Bone Marrow Pathological Lesions. .
- ClinicalTrials.gov ID
- NCT06703138
- Acronym / sponsor ID
- MRI in bone marrow lesions
- Conditions
- Diffusion MRI, Bone Marrow Disease
- Keywords
- MRI, Bone marrow pathologies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 25 Nov 2024 (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.
Bone marrow lesions are common, and imaging findings are associated with various aetiologies, as compared to conventional radiography and computed tomography (CT), MRI is a better non-invasive imaging modality to evaluate vertebral bone marrow, due to better soft-tissue contrast, so the aim of our study is the use of MRI diffusion in differentiating various vertebral bone marrow pathological lesions.
Detailed description
Bone marrow lesions are common, and imaging findings are associated with various aetiologies, such as degenerative, infectious, traumatic, malignant, metabolic, and haematopoietic .
As compared to conventional radiography and computed tomography (CT), MRI is a better non-invasive imaging modality to evaluate vertebral bone marrow, due to better soft-tissue contrast as well as being non-ionising in nature .
Although conventional MRI is essential for anatomical visualization and lesion detection in bone marrow pathologies ,but it often insufficient in distinguishing different vertebral bone marrow lesions, due to overlapping imaging features and often due to coexistence of bone marrow oedema that can be caused by fractures, infection, and bone marrow hyperplasia, thus reducing the specificity of conventional sequences .
MRI diffusion provides complementary information about tissue microstructure and cellular .it exploits the translational mobility of water molecules to obtain information on the microscopic behaviour of the tissues.
On the other hand, apparent diffusion coefficient (ADC) values provide quantitative measure of Brownian movement with low ADC values implying restricted diffusion and high values being a measure of free diffusion.
Therefore, DWI provides both qualitative and quantitative functional information concerning the microscopic movements of water at the cellular level. The benefits of DWI comprise a small scanning period that allows it to be easily included in the routine imaging protocols .
For example, In healthy bone marrow, water diffusion is relatively unrestricted due to its cellularity and vascularity, while pathologies such as metastatic disease or myelofibrosis typically exhibit restricted diffusion.
Diffusion MRI can also distinguish bone marrow edema like acute injury or inflammation, from infiltrative diseases such as multiple myeloma. Edema typically shows higher ADC values due to the increased water content, whereas infiltrative diseases reduce diffusion, resulting in lower ADC values.
These examples illustrate how MRI diffusion can differentiate various vertebral bone marrow pathological lesions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- - All adult patients with various vertebral bone marrow lesions.
Key inclusion criteria (1 listed)
- All adult patients with vertebral lesions Clinically suspected or diagnosed by other modalities as X-ray or CT were included in the study.
Key exclusion criteria (5 listed)
- Patients with metallic prosthesis which are not MRI compatible .
- patients with previous Vertebral surgery.
- patients with Vertebral Congenital anomalies
- Patients refused the examination.
- Patients who suffer from claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the efficacy of MRI diffusion in differentiation between Various Vertebral bone marrow pathological lesions. .
Time frame: Baseline
Primary (main): Establishing correlations between DWI findings and laboratory, clinical or histopathological results.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 30709475Leake RL, Mills MK, Hanrahan CJ. Spinal Marrow Imaging: Clues to Disease. Radiol Clin North Am. 2019 Mar;57(2):359-375. doi: 10.1016/j.rcl.2018.09.008. Epub 2018 Nov 17.
- Background: PubMed 27444005Lin S, Ouyang T, Kanekar S. Imaging of Bone Marrow. Hematol Oncol Clin North Am. 2016 Aug;30(4):945-71. doi: 10.1016/j.hoc.2016.03.012.
- Background: PubMed 26114411Dietrich O, Geith T, Reiser MF, Baur-Melnyk A. Diffusion imaging of the vertebral bone marrow. NMR Biomed. 2017 Mar;30(3). doi: 10.1002/nbm.3333. Epub 2015 Jun 26.
- Background: PubMed 28570033Karampinos DC, Ruschke S, Dieckmeyer M, Diefenbach M, Franz D, Gersing AS, Krug R, Baum T. Quantitative MRI and spectroscopy of bone marrow. J Magn Reson Imaging. 2018 Feb;47(2):332-353. doi: 10.1002/jmri.25769. Epub 2017 Jun 1.
- Background: PubMed 21129641Padhani AR, Koh DM. Diffusion MR imaging for monitoring of treatment response. Magn Reson Imaging Clin N Am. 2011 Feb;19(1):181-209. doi: 10.1016/j.mric.2010.10.004.
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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.
Eman A. Ahmed study director
Professor
Shimaa F. Gad study director
Assistant professor
Questions about this trial
What is this clinical trial studying?
An observational study of Diffusion MRI and Bone Marrow Disease, run by Assiut University.
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 1 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: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeinab H. Mahmoud (+201553673982, zeinab.16266288@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of MRI diffusion in differentiation between Various Vertebral bone marrow pathological lesions. . (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06703138, which also lists 5 linked publications.
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 29 Nov 2024.