Ultra-Low Dose Computed Tomography For Diagnosis And Follow-Up Of Patients With Diffuse Parenchymal Lung Disease (DPLD)

Diffuse Parenchymal Lung Disease Clinical Trial

Official title:

Ultra-Low Dose Computed Tomography For Diagnosis And Follow-Up Of Patients With Diffuse Parenchymal Lung Disease (DPLD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04392726
• Other study ID #: SHEBA-20-7020-20-SMC-LL-CTIL
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: January 30, 2024

Study information

• Verified date: May 2022
• Source: Sheba Medical Center
• Contact: Gal Varshavsky
• Phone: 972-3-5305997
• Email: Gal.Varshavsky[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary intention of this study is to determine the diagnostic performance of ultra-low-dose CT (ULDCT) in diagnosis and follow-up of diffuse parenchymal lung disease (DPLD). We hypothesize that inspiratory and expiratory chest ULDCT has comparable diagnostic yield to standard dose chest High-resolution computed tomography (HRCT) and utility for follow-up of patients with known DPLD. We will study this hypothesis through the following aims:

1. Determine whether inspiratory and expiratory ULDCT are comparable to HRCT in identifying mosaic attenuation due to air-trapping.

2. Determine whether ULDCT is as good as HRCT for follow-up of patients with established DPLD to identify disease progression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. suspected or known DPLD

2. referred to DPLD observation

Exclusion Criteria:

1. other lung related diseases

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Related Conditions & MeSH terms

• Diffuse Parenchymal Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure of this study is to determine the diagnostic performance of ULDCT in diagnosis of DPLD.	The diagnostic performance will be evaluated according to the biopsy results	during the procedure/surgery
Primary	The primary outcome measure of this study is to determine the prognostic performance of ULDCT in the follow up of DPLD.	The diagnostic performance will be evaluated according to the biopsy results	during the procedure/surgery