AzTrials
AzTrials

Lung Transplant; ComplicationsNCT04892719

4DX Functional Lung Imaging in the Diagnosis of Chronic Lung Allograft Dysfunction After Lung Transplantation

A study testing Fluoroscopic chest imaging with 4Dx technology software analysis in people with Lung Transplant; Complications, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a pilot study to determine the utility of Novel Functional Lung Imaging and Ventilation (4DxV) Analysis software in measurement of lung ventilation abnormalities and diagnosis of chronic lung allograft dysfunction (CLAD) after lung transplantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Transplant; Complications
What is being tested?
Fluoroscopic chest imaging with 4Dx technology software analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
28 Oct 2020to 31 Mar 2022
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Greater than or equal to 18 years of age at the time of written informed consent
  • Recipient of a first bilateral lung transplantation performed at Duke University at least one year prior to written informed consent
  • Computed tomography (CT) scan of the chest performed at Duke as standard of care after transplantation but within 1 year prior to written informed consent 4a. CLAD grades 1, 2,or 3 (per ISHLT 2014 criteria [Meyer et al 2014]) prior to or at the time of screening
  • Grade 1 is defined as a fractional decrease in FEV1 to 66-80% of post-transplant baseline FEV1
  • Grade 2 is defined as a fractional decrease in FEV1 to 51%-65% of post-transplant baseline FEV1
  • Grade 3 is defined as a fractional decrease in FEV1 to <= 50% of post-transplant baseline FEV14b. CLAD free status (defined as most recent FEV1 at the time of screening >90% of post-transplant baseline FEV1)

Who cannot join

  • Recipients of a single lung transplant
  • Recipients of a redo-lung transplant
  • Recipients of bone marrow or stem cell transplant
  • Recipients of a multi-organ transplant
  • Patients with hospital admissions(excluding admissions for planned treatment of the CLAD and/or rejection)within one month of screening.
  • Patients who are unable to lie flat on the fluoroscopy table
  • Pregnant women (by subject's verbal report). Lung transplant recipients are routinely counseled to avoid pregnancy due to the teratogenic effects of necessary immunosuppressant medications. Pregnancy after lung transplantation is therefore extremely rare. As this is a minimal risk study which does not involve an experimental therapy, invasive devices, or increased risk procedures, pregnancy testing is deemed unnecessary for this population for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University

    Durham, North Carolina, 27710

Other trials in United States

About this study

This is a pilot study to determine the utility of Novel Functional Lung Imaging and Ventilation (4DxV) Analysis software in measurement of lung ventilation abnormalities and diagnosis of chronic lung allograft dysfunction (CLAD) after lung transplantation.

Read the detailed description

This is a pilot study to determine the feasibility and utility of Novel Functional Lung Imaging and Ventilation (4DxV) Analysis software in measurement of lung ventilation abnormalities and diagnosis of CLAD after lung transplantation. 4DxV is a technology developed by 4Dx (4Dx Limited, Melbourne, Australia and Los Angeles, CA) and is a novel computational approach to the data obtained from standard fluoroscopic imaging that measures tissue motion of the lung at all locations and in all phases of breath. These motion measurements are used to calculate 4-dimensional ventilation (4DxV) of lung tissue to provide variety of outputs. The investigators will establish the sensitivity, specificity, and accuracy of this technology in diagnosis of CLAD compared to CT scan and pulmonary function results in patients with a known diagnosis of CLAD based on established diagnostic criteria.

The investigators will test the following hypotheses:

  1. 4DxV scans will be able to detect quantitative ventilation abnormalities in patients with established CLAD and the severity of the abnormalities will correlate with severity of PFT decline
  2. 4DxV will be able to diagnose patients with CLAD of the bronchiolitis obliterans syndrome (BOS) phenotype grades 0 (CLAD free) vs grades 1-3
Being tested
Fluoroscopic chest imaging with 4Dx technology software analysis
Keywords
Lung Transplantation, Chronic Lung Allograft Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluoroscopic chest imaging with 4Dx technology software analysisDiagnostic test

    4DxV utilizes a novel software algorithm to analyze data from cinefluoroscopy images to calculate regional ventilation and pulmonary function changes. Cinefluorography uses a fluorescent screen with X-rays to make real-time moving images the lung described below. This is the same x-ray fluoroscopy that is used in clinical imaging and the fluoroscopic imaging time is approximately 1 minute leading to an effective radiation dose of 2 mSv (200 mRem). This is significantly lower that the radiation exposure from a standard chest CT. Fluoroscopy images are acquired at each of five views for approximately enough time to capture at least one complete, continuous breath. The subject is required to remain in the same position for each of the five fluoroscopy imaging sequences. These images will be analyzed by the novel 4Dx technology to provide the 4Dx lung function analysis report.

Study groups in NCT04892719
Study groupRoleWhat they receive
Participants who underwent a lung transplant at DukeOtherParticipants will undergo fluoroscopic chest imaging with 4Dx technology software analysis
Receives: Diagnostic Test: Fluoroscopic chest imaging with 4Dx technology software analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventilation defect percentage (VDP) as measured by XV lung ventilation analysis software

    Determine the VDP using XV Lung Ventilation Analysis Software to quantify ventilation in lung transplant patients

    Measured: At least one year after lung transplantation

  2. Regional ventilation heterogeneity percentage as measured by XV lung ventilation analysis software

    Determine the ventilation heterogeneity percentage using XV Lung Ventilation Analysis Software to quantify ventilation in lung transplant patients

    Measured: At least one year after lung transplantation

Secondary outcomes (1)

  1. Calculation of Bronchiolitis Obliterans Syndrome (BOS) Stage based on FEV1 decline

    Determine BOS stage based on subject's pulmonary function test measurements of percent FEV1 decline compared to post transplant baseline FEV1

    Measured: At least one year after lung transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start28 Oct 2020
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
This study uses a case control design and approximately 15 lung transplant recipients will be enrolled (10 CLAD cases/5 CLAD free controls). The study procedures will be performed during a single research visit.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04892719
Sponsor's protocol ID
Pro00103179
Status last verified
Jul 2022
First submitted
29 Apr 2021
Last updated
28 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Meyer KC, Raghu G, Verleden GM, Corris PA, Aurora P, Wilson KC, Brozek J, Glanville AR; ISHLT/ATS/ERS BOS Task Force Committee; ISHLT/ATS/ERS BOS Task Force Committee. An international ISHLT/ATS/ERS clinical practice guideline: diagnosis and management of bronchiolitis obliterans syndrome. Eur Respir J. 2014 Dec;44(6):1479-503. doi: 10.1183/09031936.00107514. Epub 2014 Oct 30.

    PubMed 25359357

Questions about this trial

What is this clinical trial studying?

A study testing Fluoroscopic chest imaging with 4Dx technology software analysis in people with Lung Transplant; Complications, run by Duke University at 1 site in United States.

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 6 inclusion and 7 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: finished, as of the sponsor's last update on 28 Jul 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventilation defect percentage (VDP) as measured by XV lung ventilation analysis software (time frame: At least one year after lung transplantation). 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?

On the ClinicalTrials.gov record for NCT04892719, which also lists 1 linked publication.

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 28 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in