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

Lung Transplant; Complications Clinical Trial

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

Clinical 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04892719
Study type Interventional
Source Duke University
Contact
Status Completed
Phase N/A
Start date October 28, 2020
Completion date March 31, 2022
View Details
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