Difference Strain Ratio Ultrasound Elastography Between B... | NCT05752227

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

NCT05752227

Sponsor

Alexandria University

Status

Unknown status

Last Update Posted

Mar 2, 2023Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Peripheral Lung Lesions

Interventions

Transthoracic biopsy
CT chest

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Mar 2023Estimated

Completion Date

Mar 2023Estimated

First Submitted Date

Dec 23, 2022

First Submission Date that Met QC Criteria

Feb 28, 2023

First Posted Date

Mar 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2023

Last Update Posted Date

Mar 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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-)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
benign lung lesions		Patient who were diagnosed with peripheral lung lesions including consolidation, atelectasis, or cavitation	Procedure: Transthoracic biopsy Radiation: CT chest
malignant lung lesions		patients diagnosed with malignant lung lesions	Procedure: Transthoracic biopsy Radiation: CT chest

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transthoracic biopsy	Procedure	Us guided transthoracic biopsy	benign lung lesions malignant lung lesions

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Above age of 18 yrs old

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed F Abouelnour	Contact	01111609023		abouelnourahmed@gmail.com

Overall Officials

Name	Affiliation	Role
Ahmed F Abouelnour, Masters	Alexandrian University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Farag Abouelnour	Recruiting	Alexandria		00203	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study protocol and full methodology of our study to be shared

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

will be available within 6 months for 1 year

Access Criteria

abouelnourahmed@gmail.com

URL

Not provided