<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04431739</url>
  </required_header>
  <id_info>
    <org_study_id>vertebral bone marrow lesions</org_study_id>
    <nct_id>NCT04431739</nct_id>
  </id_info>
  <brief_title>Vertebral Bone Marrow Lesions by DWI and ADC Values</brief_title>
  <official_title>Differentiation Between Malignant and Benign Vertebral Bone Marrow Lesions by Diffusion Weighted Imaging (DWI) and Apparnt Diffusion Coefficient (ADC) Values</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohamed Ibrahim Abbas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the work is to assess the utility of apparent diffusion coefficient obtained in&#xD;
      diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral&#xD;
      lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MRI has a high sensitivity in delineating the pathology, its specificity is low. Osteoporotic&#xD;
      and metastatic compression fractures may be mistaken for each other in the acute phase (Wong&#xD;
      and Suresh, 2018). Edema in the acute phase of benign fractures may replace normal bone&#xD;
      marrow and cause hypointense signal changes in T1-weighted images and hyperintense signal&#xD;
      changes in T2-weighted images, at the same time taking contrast material. These changes are&#xD;
      also typical for metastasis and cause confusion in diagnosis when only one lesion is present&#xD;
      (Mauch et al., 2018).&#xD;
&#xD;
      Diffusion-weighted imaging (DWI) has recently appeared as a new method of screening in&#xD;
      characterizing lesions without necessitating contrast material and in evaluating the&#xD;
      vertebrae quantitatively (Lee et al., 2019) Diffusion-weighted-imaging (DWI) provides&#xD;
      microscopic information from water protons which is not possible using conventional magnetic&#xD;
      resonance imaging (MRI) (Partridge et al., 2017). DWI measures the random (Brownian) extra,&#xD;
      intra and transcellular motion of water molecules (Ahlawat and Fayad, 2018)&#xD;
      Apparent-diffusion-coefficient (ADC) is a quantitative parameter calculated from DWI that&#xD;
      combines the effects of capillary perfusion and water diffusion (Wang et al., 2018) In a&#xD;
      comparatively small number of surveys, ADC values have been studied in discriminating the&#xD;
      infectious lesions from the malign lesions The utility of apparent diffusion coefficient&#xD;
      obtained in diffusion-weighted MR imaging for the differentiation between benign and&#xD;
      malignant vertebral lesions, and to determine the sensitivity and the specificity in&#xD;
      differentiating benign and malignant vertebral lesions according to the optimal cutoff ADC&#xD;
      value (Dahnert et al., 2017)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging</measure>
    <time_frame>6 months</time_frame>
    <description>The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity, specificity and predictive value of the procedure</measure>
    <time_frame>6 months</time_frame>
    <description>Compared the results with histo-pathological biopsy and follow up studies after medical treatment to detect (sensitivity, specificity and predictive value) of the procedure.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Vertebral Lesion</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI including conventional MRI, DWI with multiple ADC values</intervention_name>
    <description>The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be subjected to the following:&#xD;
&#xD;
          1. Clinical picture&#xD;
&#xD;
          2. Orthopedic and neurological examination Imaging studies&#xD;
&#xD;
               -  MRI of spine (site of complain) (T1WIs and T2WIs).&#xD;
&#xD;
               -  Diffusion-Weighted Imaging (DWI) and apparent diffusion coefficient (ADC)&#xD;
                  mapping.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        After taking clinical complaint and Orthopedic and neurological examinations, all patients&#xD;
        (any age or sex) with suspected bone marrow focal lesions will undergo DWI and ADC map.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All patients who contraindicated for MRI study as patients with cardiac pacemaker, any&#xD;
        metallic stent, claustrophobia and morbid obesity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Abdel Kareem H Abdalla, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of Radio-diagnosis, Faculty of Medicine -Assuit University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed I Abbas, MD</last_name>
    <phone>01002362428</phone>
    <email>mahmoud.znaty@yahoo.com</email>
  </overall_contact>
  <results_reference>
    <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>
    <PMID>31039028</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>29348133</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>31316239</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Ibrahim Abbas</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04431739
org study id: vertebral bone marrow lesions
nct id: NCT04431739
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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)
observational model: Cohort
time perspective: Cross-Sectional
measure: The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging
time frame: 6 months
description: The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions
measure: Sensitivity, specificity and predictive value of the procedure
time frame: 6 months
description: Compared the results with histo-pathological biopsy and follow up studies after medical treatment to detect (sensitivity, specificity and predictive value) of the procedure.
intervention type: Device
intervention name: MRI including conventional MRI, DWI with multiple ADC values
description: The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
last name: Abdel Kareem H Abdalla, MD
role: Study Chair
affiliation: Professor of Radio-diagnosis, Faculty of Medicine -Assuit University
last name: Mohamed I Abbas, MD
phone: 01002362428
email: mahmoud.znaty@yahoo.com
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.
PMID: 31039028
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.
PMID: 29348133
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.
PMID: 31316239
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Ibrahim Abbas
investigator title: MD