TROFI_BE: Transplant Optimization Using Functional Imaging (TROFI)

Sponsor

FLUIDDA nv (Industry)

Overall Status

Completed

CT.gov ID

NCT02441413

Collaborator

(none)

Enrollment

Location

Arm

14.3

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans Lung Transplant Rejection	Radiation: High Resolution Computed Tomography scans	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Transplant Optimization Using Functional Imaging (TROFI)

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Nov 8, 2016

Actual Study Completion Date :

Nov 8, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HRCT scans HRCT scan will be taken	Radiation: High Resolution Computed Tomography scans 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. Other Names: HRCT scan

Arm

Intervention/Treatment

Experimental: HRCT scans

HRCT scan will be taken

Radiation: High Resolution Computed Tomography scans

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.

Other Names:

HRCT scan

Outcome Measures

Primary Outcome Measures

Airway Volume (iVaw) 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.
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.
Internal Lobar Airflow Distribution 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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