Transplant Optimization Using Functional Imaging (TROFI) (TROFI_BE)

March 28, 2017 updated by: FLUIDDA nv
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Antwerp University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FLUIDDA nv

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

November 8, 2016

Study Completion (Actual)

November 8, 2016

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLUI-2014-103_BE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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