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Transplant Optimization Using Functional Imaging (TROFI) (TROFI_BE)

Primary Purpose

Bronchiolitis Obliterans, Lung Transplant Rejection

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
High Resolution Computed Tomography scans
Sponsored by
FLUIDDA nv
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchiolitis Obliterans focused on measuring HRCT, High Resolution Computed Tomography scans, Functional Respiratory Imaging, FRI, Computed Tomography, CT, Bronchiolitis Obliterans Syndrome, BOS, Lung Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

  • Pregnant or lactating female
  • Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation

Sites / Locations

  • Antwerp University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HRCT scans

Arm Description

HRCT scan will be taken

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 28, 2015
Last Updated
March 28, 2017
Sponsor
FLUIDDA nv
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1. Study Identification

Unique Protocol Identification Number
NCT02441413
Brief Title
Transplant Optimization Using Functional Imaging (TROFI)
Acronym
TROFI_BE
Official Title
Transplant Optimization Using Functional Imaging (TROFI)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 8, 2016 (Actual)
Study Completion Date
November 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FLUIDDA nv

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis Obliterans, Lung Transplant Rejection
Keywords
HRCT, High Resolution Computed Tomography scans, Functional Respiratory Imaging, FRI, Computed Tomography, CT, Bronchiolitis Obliterans Syndrome, BOS, Lung Transplant

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HRCT scans
Arm Type
Experimental
Arm Description
HRCT scan will be taken
Intervention Type
Radiation
Intervention Name(s)
High Resolution Computed Tomography scans
Other Intervention Name(s)
HRCT scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Airway Volume (iVaw) using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Time Frame
12 months
Title
Airway Resistance (iRaw) using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Time Frame
12 months
Title
Specific Airway Volume (siVaw) using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Time Frame
12 months
Title
Specific Airway Resistance (siRaw) using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Time Frame
12 months
Title
Lobe Volumes (iVlobes) using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Time Frame
12 months
Title
Air Trapping using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Time Frame
12 months
Title
Internal Lobar Airflow Distribution using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Time Frame
12 months
Title
Low attenuation or Emphysema Score using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Time Frame
12 months
Title
Blood Vessel Density or Fibrosis Score using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Time Frame
12 months
Title
Airway Wall Thickness using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried De Backer, M.D., M.S.
Organizational Affiliation
University Hospital of Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

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Transplant Optimization Using Functional Imaging (TROFI)

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