- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04431739
Vertebral Bone Marrow Lesions by DWI and ADC Values
Differentiation Between Malignant and Benign Vertebral Bone Marrow Lesions by Diffusion Weighted Imaging (DWI) and Apparnt Diffusion Coefficient (ADC) Values
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mohamed I Abbas, MD
- Phone Number: 01002362428
- Email: mahmoud.znaty@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients will be subjected to the following:
- Clinical picture
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.
Description
Inclusion Criteria:
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.
Exclusion Criteria:
All patients who contraindicated for MRI study as patients with cardiac pacemaker, any metallic stent, claustrophobia and morbid obesity.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity, specificity and predictive value of the procedure
Time Frame: 6 months
|
Compared the results with histo-pathological biopsy and follow up studies after medical treatment to detect (sensitivity, specificity and predictive value) of the procedure.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Abdel Kareem H Abdalla, MD, Professor of Radio-diagnosis, Faculty of Medicine -Assuit University
Publications and helpful links
General 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.
- Mauch 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.
- Lee 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- vertebral bone marrow lesions
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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