Vertebral LesionNCT04431739
Vertebral Bone Marrow Lesions by DWI and ADC Values
An observational study of Vertebral Lesion, run by Mohamed Ibrahim Abbas.
Trial summary
The aim of the work is to assess the utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vertebral Lesion
- What is being tested?
- MRI including conventional MRI, DWI with multiple ADC values
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to Aug 2021
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients will be subjected to the following: 1. Clinical picture 2. Orthopedic and neurological examination Imaging studies * MRI of spine (site of complain) (T1WIs and T2WIs). * Diffusion-Weighted Imaging (DWI) and apparent diffusion coefficient (ADC) mapping.
Who may be able to join
- After taking clinical complaint and Orthopedic and neurological examinations, all patients (any age or sex) with suspected bone marrow focal lesions will undergo DWI and ADC map.
Who cannot join
- All patients who contraindicated for MRI study as patients with cardiac pacemaker, any metallic stent, claustrophobia and morbid obesity.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Differentiation Between Malignant and Benign Vertebral Bone Marrow Lesions by Diffusion Weighted Imaging (DWI) and Apparnt Diffusion Coefficient (ADC) Values
The aim of the work is to assess the utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions.
Read the detailed description
MRI has a high sensitivity in delineating the pathology, its specificity is low. Osteoporotic and metastatic compression fractures may be mistaken for each other in the acute phase (Wong and Suresh, 2018). Edema in the acute phase of benign fractures may replace normal bone marrow and cause hypointense signal changes in T1-weighted images and hyperintense signal changes in T2-weighted images, at the same time taking contrast material. These changes are also typical for metastasis and cause confusion in diagnosis when only one lesion is present (Mauch et al., 2018).
Diffusion-weighted imaging (DWI) has recently appeared as a new method of screening in characterizing lesions without necessitating contrast material and in evaluating the vertebrae quantitatively (Lee et al., 2019) Diffusion-weighted-imaging (DWI) provides microscopic information from water protons which is not possible using conventional magnetic resonance imaging (MRI) (Partridge et al., 2017). DWI measures the random (Brownian) extra, intra and transcellular motion of water molecules (Ahlawat and Fayad, 2018) Apparent-diffusion-coefficient (ADC) is a quantitative parameter calculated from DWI that combines the effects of capillary perfusion and water diffusion (Wang et al., 2018) In a comparatively small number of surveys, ADC values have been studied in discriminating the infectious lesions from the malign lesions The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions, and to determine the sensitivity and the specificity in differentiating benign and malignant vertebral lesions according to the optimal cutoff ADC value (Dahnert et al., 2017)
- Conditions
- Vertebral Lesion
- Being tested
- MRI including conventional MRI, DWI with multiple ADC values
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI including conventional MRI, DWI with multiple ADC valuesDevice
The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging
The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions
Measured: 6 months
Secondary outcomes (1)
Sensitivity, specificity and predictive value of the procedure
Compared the results with histo-pathological biopsy and follow up studies after medical treatment to detect (sensitivity, specificity and predictive value) of the procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vertebral LesionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Ibrahim Abbas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Ibrahim Abbas, Assiut University
- Investigators
- Abdel Kareem H Abdalla, MD, Study chair, Professor of Radio-diagnosis, Faculty of Medicine -Assuit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431739
- Sponsor's protocol ID
- vertebral bone marrow lesions
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li K, Huang L, Lang Z, Ni L, Du J, Yang H. Reliability and Validity of Different MRI Sequences in Improving the Accuracy of Differential Diagnosis of Benign and Malignant Vertebral Fractures: A Meta-Analysis. AJR Am J Roentgenol. 2019 Aug;213(2):427-436. doi: 10.2214/AJR.18.20560. Epub 2019 Apr 30.
PubMed 31039028Mauch JT, Carr CM, Cloft H, Diehn FE. Review of the Imaging Features of Benign Osteoporotic and Malignant Vertebral Compression Fractures. AJNR Am J Neuroradiol. 2018 Sep;39(9):1584-1592. doi: 10.3174/ajnr.A5528. Epub 2018 Jan 18.
PubMed 29348133Lee K, Park HY, Kim KW, Lee AJ, Yoon MA, Chae EJ, Lee JH, Chung HW. Advances in whole body MRI for musculoskeletal imaging: Diffusion-weighted imaging. J Clin Orthop Trauma. 2019 Jul-Aug;10(4):680-686. doi: 10.1016/j.jcot.2019.05.018. Epub 2019 May 29.
PubMed 31316239
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiation Between Malignant and Benign Vertebral Bone Marrow Lesions by Diffusion Weighted Imaging (DWI) and Apparnt Diffusion Coefficient (ADC) Values
- ClinicalTrials.gov ID
- NCT04431739
- Acronym / sponsor ID
- vertebral bone marrow lesions
- Conditions
- Vertebral Lesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mohamed Ibrahim AbbasUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 16 Jun 2020 (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 aim of the work is to assess the utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions.
Detailed description
MRI has a high sensitivity in delineating the pathology, its specificity is low. Osteoporotic and metastatic compression fractures may be mistaken for each other in the acute phase (Wong and Suresh, 2018). Edema in the acute phase of benign fractures may replace normal bone marrow and cause hypointense signal changes in T1-weighted images and hyperintense signal changes in T2-weighted images, at the same time taking contrast material. These changes are also typical for metastasis and cause confusion in diagnosis when only one lesion is present (Mauch et al., 2018).
Diffusion-weighted imaging (DWI) has recently appeared as a new method of screening in characterizing lesions without necessitating contrast material and in evaluating the vertebrae quantitatively (Lee et al., 2019) Diffusion-weighted-imaging (DWI) provides microscopic information from water protons which is not possible using conventional magnetic resonance imaging (MRI) (Partridge et al., 2017). DWI measures the random (Brownian) extra, intra and transcellular motion of water molecules (Ahlawat and Fayad, 2018) Apparent-diffusion-coefficient (ADC) is a quantitative parameter calculated from DWI that combines the effects of capillary perfusion and water diffusion (Wang et al., 2018) In a comparatively small number of surveys, ADC values have been studied in discriminating the infectious lesions from the malign lesions The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions, and to determine the sensitivity and the specificity in differentiating benign and malignant vertebral lesions according to the optimal cutoff ADC value (Dahnert et al., 2017)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be subjected to the following: 1. Clinical picture 2. Orthopedic and neurological examination Imaging studies * MRI of spine (site of complain) (T1WIs and T2WIs). * Diffusion-Weighted Imaging (DWI) and apparent diffusion coefficient (ADC) mapping.
Key inclusion criteria (1 listed)
- After taking clinical complaint and Orthopedic and neurological examinations, all patients (any age or sex) with suspected bone marrow focal lesions will undergo DWI and ADC map.
Key exclusion criteria (1 listed)
- All patients who contraindicated for MRI study as patients with cardiac pacemaker, any metallic stent, claustrophobia and morbid obesity.
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 |
|---|---|---|
| MRI including conventional MRI, DWI with multiple ADC valuesThe utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions | Device | – |
Primary outcome
The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging
Time frame: 6 months
The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions
1 secondary outcome
Sensitivity, specificity and predictive value of the procedure
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Results publication: PubMed 31039028Li K, Huang L, Lang Z, Ni L, Du J, Yang H. Reliability and Validity of Different MRI Sequences in Improving the Accuracy of Differential Diagnosis of Benign and Malignant Vertebral Fractures: A Meta-Analysis. AJR Am J Roentgenol. 2019 Aug;213(2):427-436. doi: 10.2214/AJR.18.20560. Epub 2019 Apr 30.
- Results publication: PubMed 29348133Mauch JT, Carr CM, Cloft H, Diehn FE. Review of the Imaging Features of Benign Osteoporotic and Malignant Vertebral Compression Fractures. AJNR Am J Neuroradiol. 2018 Sep;39(9):1584-1592. doi: 10.3174/ajnr.A5528. Epub 2018 Jan 18.
- Results publication: PubMed 31316239Lee K, Park HY, Kim KW, Lee AJ, Yoon MA, Chae EJ, Lee JH, Chung HW. Advances in whole body MRI for musculoskeletal imaging: Diffusion-weighted imaging. J Clin Orthop Trauma. 2019 Jul-Aug;10(4):680-686. doi: 10.1016/j.jcot.2019.05.018. Epub 2019 May 29.
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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.
Abdel Kareem H Abdalla, MD study chair
Professor of Radio-diagnosis, Faculty of Medicine -Assuit University
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Lesion, run by Mohamed Ibrahim Abbas.
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 1 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 16 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed I Abbas, MD (01002362428, mahmoud.znaty@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging (time frame: 6 months). 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 NCT04431739, which also lists 3 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 16 Jun 2020.