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

Difference In Strain Ratio Ultrasound Elastography Between Benign And Malignant Peripheral Parenchymal Lung Lesions.

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Lung Lesions
• Intervention / Treatment: Procedure: Transthoracic biopsy; Radiation: CT chest

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Ahmed F Abouelnour; Phone Number: 01111609023; Email: abouelnourahmed@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt, 00203
    • Recruiting
    • Ahmed Farag Abouelnour
    • Contact: Ahmed Abouelnour; Phone Number: 01111609023; Email: abouelnourahmed@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients are all above age of 18 yrs old without gender discrimination

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
benign lung lesions; Patient who were diagnosed with peripheral lung lesions including consolidation, atelectasis, or cavitation	Procedure: Transthoracic biopsy; Us guided transthoracic biopsy; Radiation: CT chest; Computed tomography
malignant lung lesions; patients diagnosed with malignant lung lesions	Procedure: Transthoracic biopsy; Us guided transthoracic biopsy; Radiation: CT chest; Computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cut off value strain ratio	To differentiate between benign and malignant lung lesions using strain ratio	6-9 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Ahmed F Abouelnour, Masters, Alexandrian University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 0201692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol and full methodology of our study to be shared
• IPD Sharing Time Frame: will be available within 6 months for 1 year
• IPD Sharing Access Criteria: abouelnourahmed@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No