NCT04892719

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Lung Transplant; Complications

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fluoroscopic chest imaging with 4Dx technology software analysis	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.

Timeline

• Start date: 2020-10-28
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-05-19
• Last updated: 2022-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study