<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/NCT03760094</url>
  </required_header>
  <id_info>
    <org_study_id>Color Doppler Ultrasound</org_study_id>
    <nct_id>NCT03760094</nct_id>
  </id_info>
  <brief_title>Role of Color Doppler Ultrasound in Lymphadenopathy</brief_title>
  <official_title>Role of Color Doppler Ultrasound in Differentiation Between Benign and Malignant Lymphadenopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lymphadenopathy is defined as an abnormality in the size or character of lymph nodes caused&#xD;
      by the invasion or propagation of either inflammatory or neoplastic cells into the nodes&#xD;
      Accurate lymph node characterization is important for a wide number of clinical situations,&#xD;
      including prognosis, prediction, selecting and monitoring treatment, beyond the diagnosis&#xD;
      itself (cancer, lymphoma, or inflammatory nodes)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Various ultrasound criteria that can help in differentiation of benign and malignant lymph&#xD;
      nodes have been well described in literature. On Gray scale ultrasound imaging, the benign&#xD;
      enlarged lymph nodes are hypoechoic, oval shaped with smooth border and echogenic hilum. On&#xD;
      the other hand, the malignant lymph nodes are round with short to long axis ratio &gt;0.5 and&#xD;
      show loss of echogenic hilum, while the Color and Power Doppler features documented for the&#xD;
      diagnosis of malignant lymph nodes are peripheral and mixed vascularity, with resistive index&#xD;
      (RI) more than 0.8, and pulsatility index (PI) more than 1.5 Although Color Doppler&#xD;
      ultrasound improves diagnostic accuracy and plays an important adjuvant role to Gray scale&#xD;
      ultrasound in differentiating benign from malignant lymph nodes as it adds to the diagnostic&#xD;
      confidence of predicting malignancy in enlarged lymph nodes, and also is useful if Gray scale&#xD;
      ultrasound findings are equivocal. However, it can neither replace histopathology nor can&#xD;
      eliminate the need for biopsy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of patients with benign lymphadenopathy</measure>
    <time_frame>one year</time_frame>
    <description>comparison with the biopsy result</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Lymph Node Disease</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with lymphadenopathy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Colour Doppler</intervention_name>
    <description>evaluation of lymph nodes by Doppler</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinically enlarged lymph nodes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous medical treatment or radiotherapy&#xD;
&#xD;
          -  previous biopsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mina Gergis Naeem</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphadenopathy</mesh_term>
  </condition_browse>
  <!-- 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/NCT03760094
org study id: Color Doppler Ultrasound
nct id: NCT03760094
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lymphadenopathy is defined as an abnormality in the size or character of lymph nodes caused
      by the invasion or propagation of either inflammatory or neoplastic cells into the nodes
      Accurate lymph node characterization is important for a wide number of clinical situations,
      including prognosis, prediction, selecting and monitoring treatment, beyond the diagnosis
      itself (cancer, lymphoma, or inflammatory nodes)
Various ultrasound criteria that can help in differentiation of benign and malignant lymph
      nodes have been well described in literature. On Gray scale ultrasound imaging, the benign
      enlarged lymph nodes are hypoechoic, oval shaped with smooth border and echogenic hilum. On
      the other hand, the malignant lymph nodes are round with short to long axis ratio >0.5 and
      show loss of echogenic hilum, while the Color and Power Doppler features documented for the
      diagnosis of malignant lymph nodes are peripheral and mixed vascularity, with resistive index
      (RI) more than 0.8, and pulsatility index (PI) more than 1.5 Although Color Doppler
      ultrasound improves diagnostic accuracy and plays an important adjuvant role to Gray scale
      ultrasound in differentiating benign from malignant lymph nodes as it adds to the diagnostic
      confidence of predicting malignancy in enlarged lymph nodes, and also is useful if Gray scale
      ultrasound findings are equivocal. However, it can neither replace histopathology nor can
      eliminate the need for biopsy
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The percentage of patients with benign lymphadenopathy
time frame: one year
description: comparison with the biopsy result
arm group label: Study group
arm group type: Experimental
description: patients with lymphadenopathy
intervention type: Device
intervention name: Colour Doppler
description: evaluation of lymph nodes by Doppler
arm group label: Study group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mina Gergis Naeem
investigator title: Principal investigator
mesh term: Lymphadenopathy