Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05752227
Other study ID # 0201692
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date March 2023

Study information

Verified date November 2022
Source Alexandria University
Contact Ahmed F Abouelnour
Phone 01111609023
Email abouelnourahmed@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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-)


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Transthoracic biopsy
Us guided transthoracic biopsy
Radiation:
CT chest
Computed tomography

Locations

Country Name City State
Egypt Ahmed Farag Abouelnour Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cut off value strain ratio To differentiate between benign and malignant lung lesions using strain ratio 6-9 months
See also
  Status Clinical Trial Phase
Completed NCT04066699 - Percutaneous Localization: Open-label Registry of Thoracic Surgery
Recruiting NCT06412289 - Comparison of the Diagnostic Accuracy Between US-guided Percutaneous Lung Biopsies vs CT-guided in Peripheral Lung Lesions N/A
Not yet recruiting NCT05799014 - The Effectiveness and Safety of Electromagnetic Navigation Real-time Guided Percutaneous Lung Biopsy N/A
Completed NCT02582944 - Electromagnetic Navigation for Peripheral Pulmonary Lesions Phase 1
Withdrawn NCT03536026 - Localization of Peripheral Pulmonary Lesions: A Pilot Study Phase 1