Difference Strain Ratio Ultrasound Elastography Between Benign and Malignant Peripheral Lung Lesions

Recruiting

• Conditions: Peripheral Lung Lesions
• Interventions: Procedure: Transthoracic biopsy; Radiation: CT chest

• Registration Number: NCT05752227
• Lead Sponsor: Alexandria University

Brief Summary

Diagnostic accuracy study to investigate the sensitivity and specificity of sonographic elastography using strain ratio to differentiate between benign and malignant peripheral lesions in comparison to biopsy, clinically, or radiologically.

Detailed Description

This is a diagnostic accuracy study with comparison to gold standard tests e.g., chest computed tomography, transthoracic biopsy, or microbiological analysis. All patients included in this study will give informed consent according to the guidelines of ethics committee, Alexandria Faculty of Medicine. (http://www.med.alexu.edu.eg/wp-content/uploads/2012/04/Checklist-FINAL- 20141.pdf-)

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2022-11
• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Primary Completion: 2023-03
• Study Completion: 2023-03
• Study First Posted: 2023-03-02
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 1. Adult patients above age of 18 years old. 2) Patients with peripheral lung lesion.

Exclusion Criteria

1. Pure pleural lesions.
2. Clinical instability to reach the final diagnosis.
3. Inaccessibility by ultrasound.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
malignant lung lesions	CT chest	patients diagnosed with malignant lung lesions
benign lung lesions	CT chest	Patient who were diagnosed with peripheral lung lesions including consolidation, atelectasis, or cavitation
benign lung lesions	Transthoracic biopsy	Patient who were diagnosed with peripheral lung lesions including consolidation, atelectasis, or cavitation
malignant lung lesions	Transthoracic biopsy	patients diagnosed with malignant lung lesions

Primary Outcome Measures

Name	Time	Method
Cut off value strain ratio	6-9 months	To differentiate between benign and malignant lung lesions using strain ratio

Trial Locations

Locations (1)

Ahmed Farag Abouelnour; 🇪🇬 Alexandria, Egypt