Transplant Optimization Using Functional Imaging (TROFI)

FLUIDDA nv3 enrolled

Overview

The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust and automated segmentation algorithms will be developed for these parameters, focusing on quantitative computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics tool. The evolution of BOS over time will be monitored using nmon-rigid image registration methods.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Bronchiolitis Obliterans Lung Transplant Rejection

Interventions

High Resolution Computed Tomography scansRADIATION

A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, visit 2, visit 3, visit 4 and visit 5. An Upper Airway (UA) scan will be taken on visit 1.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female patient ≥ 18 years old * Written informed consent obtained * Patient who had undergone a lung transplant a year ago or more * Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before screening visit and will continue to use a contraception method during the study * The patient must be able to perform the lung monitoring at home * Patients diagnosed with BOS 0, BOS 0-p or BOS 1 Exclusion Criteria: * Pregnant or lactating female * Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation

Locations (1)

Antwerp University Hospital

Edegem, Antwerp, Belgium