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
About this trial
This is an interventional diagnostic trial for Lymph Node Disease
Eligibility Criteria
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
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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