Role of Lung Ultrasound in Screening for Interstitial Lun... | NCT06531785

Studies
Role of Lung Ultrasound in Screening for Interstitial Lung Disease in Patients With Rheumatoid Arthritis

NCT06531785

Sponsor

Assiut University

Status

Completed

Last Update Posted

Aug 28, 2025Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Interstitial Lung Disease
Rheumatoid Arthritis

Interventions

chest ultrasound

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Jun 1, 2025Actual

Completion Date

Aug 1, 2025Actual

First Submitted Date

Jul 29, 2024

First Submission Date that Met QC Criteria

Jul 29, 2024

First Posted Date

Aug 1, 2024Actual

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

Aug 22, 2025

Last Update Posted Date

Aug 28, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Waleed Gamal Elddin Khaleel, Assistant Professor of Chest Diseases, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

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

The aim of this observational cross-sectional study is to assess accuracy of Lung Ultrasound to early diagnose ILD among Rheumatoid arthritis patients. Rheumatoid arthritis patients with suggestive history of chest troubles will be evaluated using chest ultrasound and high resolution CT chest to evaluate ability of chest ultrasound to early diagnose ILD among rheumatoid arthritis patients.

Detailed Description

Interstitial lung disease (ILD) is a common complication of connective tissue disease (CTD) and a leading cause of morbidity and mortality. Thus, early diagnosis and treatment may improve the prognosis of patients with ILD.

High-resolution computed tomography (HRCT) is the gold standard for ILD diagnosis. It can detect the location and type of lesions through its high resolution. Unfortunately, it is hampered by high cost and potential risks associated with radiation exposure, especially for pregnant women.

Accordingly, finding a low-cost, non-invasive, and non-ionizing diagnostic method is necessary for ILD. Lung ultrasound (LUS) has all of these advantages and is an accessible bedside procedure. As a result, it is easily accepted by patients. Over the last 20 years, LUS has mainly been applied in CTD-ILD diagnosis, where it has shown high sensitivity and specificity. The assessment of ILD by LUS is determined by the number of B-lines, which appear as a comet tail signal and originate from the pleural line without fading to the edge of the screen.

The total number of B-lines was found to correlate well with the HRCT score. To assess the number of B-lines, previous studies used various scoring systems by designing different intercostal spaces (LIS), such as 72 LIS, 50 LIS, and 14 LIS. This study aims to assess Lung ultrasound as a screening tool for early interstitial lung disease in connective tissue disease patients.

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

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
chest ultrasound	Device	Lung ultrasound to early diagnose ILD among rheumatoid arthritis patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of rheumatoid arthritis patients that can be diagnosed early with Interstitial lung disease.	early diagnosis of Interstitial lung disease among rheumatoid arthritis patients using chest ultrasound versus high resolution computed tomography	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of rheumatoid arthritis and suspicion of interstitial lung disease on history and/ or clinical examination, age > 18 years

Exclusion Criteria:

Patients who refuse to participate in the study,
Patients with a history of pulmonary neoplasia or
Patients with causes of interstitial fluid, such as, heart failure, diastolic dysfunction, asthma or pulmonary edema.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Confirmed diagnosis of rheumatoid arthritis and suspicion of interstitial lung disease on history and/ or clinical examination, age > 18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Waleed MD Gamal Elddin Khaleel, Ass. Prof.	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Assiut University		Asyut		711111	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29718851	Background	Tardella M, Di Carlo M, Carotti M, Filippucci E, Grassi W, Salaffi F. Ultrasound B-lines in the evaluation of interstitial lung disease in patients with systemic sclerosis: Cut-off point definition for the presence of significant pulmonary fibrosis. Medicine (Baltimore). 2018 May;97(18):e0566. doi: 10.1097/MD.0000000000010566.
26483318

ID	Term
D017563	Lung Diseases, Interstitial
D001172	Arthritis, Rheumatoid

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D001168	Arthritis
D007592	Joint Diseases