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

NCT ID: NCT05752227

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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-)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Lung Lesions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

benign lung lesions

Patient who were diagnosed with peripheral lung lesions including consolidation, atelectasis, or cavitation

Transthoracic biopsy

Intervention Type PROCEDURE

Us guided transthoracic biopsy

CT chest

Intervention Type RADIATION

Computed tomography

malignant lung lesions

patients diagnosed with malignant lung lesions

Transthoracic biopsy

Intervention Type PROCEDURE

Us guided transthoracic biopsy

CT chest

Intervention Type RADIATION

Computed tomography

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transthoracic biopsy

Us guided transthoracic biopsy

Intervention Type PROCEDURE

CT chest

Computed tomography

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexandria University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed F Abouelnour, Masters

Role: PRINCIPAL_INVESTIGATOR

Alexandrian University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ahmed Farag Abouelnour

Alexandria, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmed F Abouelnour

Role: CONTACT

01111609023

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ahmed Abouelnour

Role: primary

01111609023

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0201692

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.