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Role of Color Doppler Ultrasound in Lymphadenopathy

Primary Purpose

Lymph Node Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Colour Doppler
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymph Node Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinically enlarged lymph nodes

Exclusion Criteria:

  • previous medical treatment or radiotherapy
  • previous biopsy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Study group

    Arm Description

    patients with lymphadenopathy

    Outcomes

    Primary Outcome Measures

    The percentage of patients with benign lymphadenopathy
    comparison with the biopsy result

    Secondary Outcome Measures

    Full Information

    First Posted
    November 29, 2018
    Last Updated
    November 29, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03760094
    Brief Title
    Role of Color Doppler Ultrasound in Lymphadenopathy
    Official Title
    Role of Color Doppler Ultrasound in Differentiation Between Benign and Malignant Lymphadenopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2018 (Anticipated)
    Primary Completion Date
    December 1, 2019 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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)
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymph Node Disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    patients with lymphadenopathy
    Intervention Type
    Device
    Intervention Name(s)
    Colour Doppler
    Intervention Description
    evaluation of lymph nodes by Doppler
    Primary Outcome Measure Information:
    Title
    The percentage of patients with benign lymphadenopathy
    Description
    comparison with the biopsy result
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: clinically enlarged lymph nodes Exclusion Criteria: previous medical treatment or radiotherapy previous biopsy

    12. IPD Sharing Statement

    Learn more about this trial

    Role of Color Doppler Ultrasound in Lymphadenopathy

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