Ultra-Low Dose Computed Tomography For Diagnosis And Foll... | NCT04392726

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

NCT04392726

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

May 10, 2022Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Diffuse Parenchymal Lung Disease

Interventions

Not provided

Countries

Israel

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

May 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

Aug 1, 2020Actual

Primary Completion Date

Jan 30, 2024Estimated

Completion Date

Jan 30, 2024Estimated

First Submitted Date

Mar 22, 2020

First Submission Date that Met QC Criteria

May 13, 2020

First Posted Date

May 19, 2020Actual

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

May 9, 2022

Last Update Posted Date

May 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 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:

Determine whether inspiratory and expiratory ULDCT are comparable to HRCT in identifying mosaic attenuation due to air-trapping.
Determine whether ULDCT is as good as HRCT for follow-up of patients with established DPLD to identify disease progression.

Detailed Description

Not provided

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

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

suspected or known DPLD
referred to DPLD observation

Exclusion Criteria:

1. other lung related diseases

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with known or suspected DPLD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gal Varshavsky	Contact	972-3-5305997		Gal.Varshavsky@sheba.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center	Recruiting	Ramat Gan			Israel

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

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