Transplant Optimization Using Functional Imaging (TROFI)

Not Applicable

Completed

• Conditions: Lung Transplant Rejection; Bronchiolitis Obliterans
• Interventions: Radiation: High Resolution Computed Tomography scans

• Registration Number: NCT02441413
• Lead Sponsor: FLUIDDA nv

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Study Start: 2015-09
• Status Verified: 2016-02
• Primary Completion: 2016-11-08
• Study Completion: 2016-11-08
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRCT scans	High Resolution Computed Tomography scans	HRCT scan will be taken

Primary Outcome Measures

Name	Time	Method
Airway Volume (iVaw) using FRI	12 months	Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Lobe Volumes (iVlobes) using FRI	12 months	Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Air Trapping using FRI	12 months	Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Airway Resistance (iRaw) using FRI	12 months	Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Specific Airway Volume (siVaw) using FRI	12 months	Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Specific Airway Resistance (siRaw) using FRI	12 months	Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Low attenuation or Emphysema Score using FRI	12 months	Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Blood Vessel Density or Fibrosis Score using FRI	12 months	Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Airway Wall Thickness using FRI	12 months	Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Internal Lobar Airflow Distribution using FRI	12 months	Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium