Vertebral Bone Marrow Lesions by DWI and ADC Values

June 12, 2020 updated by: Mohamed Ibrahim Abbas

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.

Study Overview

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

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Abdel Kareem H Abdalla, MD, Professor of Radio-diagnosis, Faculty of Medicine -Assuit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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