NCT05752227

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
Last Updated

March 2, 2023

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

December 23, 2022

Last Update Submit

February 28, 2023

Conditions

Peripheral Lung Lesions

Outcome Measures

Primary Outcomes (1)

  • Cut off value strain ratio

    To differentiate between benign and malignant lung lesions using strain ratio

    6-9 months

Study Arms (2)

benign lung lesions

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

Procedure: Transthoracic biopsyRadiation: CT chest

malignant lung lesions

patients diagnosed with malignant lung lesions

Procedure: Transthoracic biopsyRadiation: CT chest

Interventions

Transthoracic biopsyPROCEDURE

Us guided transthoracic biopsy

benign lung lesionsmalignant lung lesions
CT chestRADIATION

Computed tomography

benign lung lesionsmalignant lung lesions

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAbove age of 18 yrs old
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Farag Abouelnour

Alexandria, 00203, Egypt

RECRUITING

Study Officials

  • Ahmed F Abouelnour, Masters

    Alexandrian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed F Abouelnour

CONTACT

01111609023abouelnourahmed@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2022

First Posted

March 2, 2023

Study Start

June 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 2, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Study protocol and full methodology of our study to be shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
will be available within 6 months for 1 year
Access Criteria
abouelnourahmed@gmail.com

Locations

EG(1)