Diffuse Parenchymal Lung DiseaseNCT04392726
Ultra-Low Dose Computed Tomography For Diagnosis And Follow-Up Of Patients With Diffuse Parenchymal Lung Disease (DPLD)
An observational study of Diffuse Parenchymal Lung Disease, run by Sheba Medical Center at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diffuse Parenchymal Lung Disease
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2020to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients with known or suspected DPLD
Who may be able to join
- suspected or known DPLD
- referred to DPLD observation
Who cannot join
- 1. other lung related diseases
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diffuse Parenchymal Lung Disease
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with suspected DPLD | Not described | |
| patients with known DPLD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: during the procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Aug 2020
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Parenchymal Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Liran Levy, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392726
- Sponsor's protocol ID
- SHEBA-20-7020-20-SMC-LL-CTIL
- Status last verified
- May 2022
- First submitted
- 22 Mar 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-Low Dose Computed Tomography For Diagnosis And Follow-Up Of Patients With Diffuse Parenchymal Lung Disease (DPLD)
- ClinicalTrials.gov ID
- NCT04392726
- Acronym / sponsor ID
- SHEBA-20-7020-20-SMC-LL-CTIL
- Conditions
- Diffuse Parenchymal Lung Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with suspected DPLD | – | – |
| patients with known DPLD | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with known or suspected DPLD
Key inclusion criteria (2 listed)
- suspected or known DPLD
- referred to DPLD observation
Key exclusion criteria (2 listed)
- 1. other lung related diseases
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome measure of this study is to determine the diagnostic performance of ULDCT in diagnosis of DPLD.
Time frame: during the procedure/surgery
The diagnostic performance will be evaluated according to the biopsy results
The primary outcome measure of this study is to determine the prognostic performance of ULDCT in the follow up of DPLD.
Time frame: during the procedure/surgery
The diagnostic performance will be evaluated according to the biopsy results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Parenchymal Lung Disease, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gal Varshavsky (972-3-5305997, Gal.Varshavsky@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure of this study is to determine the diagnostic performance of ULDCT in diagnosis of DPLD. (time frame: during the procedure/surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.