NCT04392726

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:

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

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Typical duration 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

First Submitted

Initial submission to the registry

March 22, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

3.5 years

First QC Date

March 22, 2020

Last Update Submit

May 9, 2022

Conditions

Diffuse Parenchymal Lung Disease

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

patients with suspected DPLD

patients with known DPLD

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with known or suspected DPLD

You may qualify if:

  • suspected or known DPLD
  • referred to DPLD observation

You may not qualify if:

  • \. other lung related diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Central Study Contacts

Gal Varshavsky

CONTACT

972-3-5305997Gal.Varshavsky@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Transplant pulmonologist

Study Record Dates

First Submitted

March 22, 2020

First Posted

May 19, 2020

Study Start

August 1, 2020

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations

IL(1)