Clinical trial NCT04431739: Vertebral Bone Marrow Lesions by DWI and ADC Values
Official title: Differentiation Between Malignant and Benign Vertebral Bone Marrow Lesions by Diffusion Weighted Imaging (DWI) and Apparnt Diffusion Coefficient (ADC) Values
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vertebral Lesion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging
timeFrame: 6 months
Secondary outcomes:
measure: Sensitivity, specificity and predictive value of the procedure
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Radio-diagnosis, Faculty of Medicine -Assuit University
name: Abdel Kareem H Abdalla, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.