Transplant Optimization Using Functional Imaging (TROFI) (TROFI_BE)

Study Description

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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	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	3 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Transplant Optimization Using Functional Imaging (TROFI)
Study Start Date :	September 2015
Actual Primary Completion Date :	November 8, 2016
Actual Study Completion Date :	November 8, 2016

Arms and Interventions

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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 Name: HRCT scan

Outcome Measures

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Primary Outcome Measures :

1. Airway Volume (iVaw) using FRI [ Time Frame: 12 months ]
   Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
2. Airway Resistance (iRaw) using FRI [ Time Frame: 12 months ]
   Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
3. Specific Airway Volume (siVaw) using FRI [ Time Frame: 12 months ]
   Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
4. Specific Airway Resistance (siRaw) using FRI [ Time Frame: 12 months ]
   Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
5. Lobe Volumes (iVlobes) using FRI [ Time Frame: 12 months ]
   Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
6. Air Trapping using FRI [ Time Frame: 12 months ]
   Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
7. Internal Lobar Airflow Distribution using FRI [ Time Frame: 12 months ]
   Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
8. Low attenuation or Emphysema Score using FRI [ Time Frame: 12 months ]
   Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.
9. 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.
10. Airway Wall Thickness using FRI [ Time Frame: 12 months ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650

Sponsors and Collaborators

FLUIDDA nv

Investigators

Principal Investigator:	Wilfried De Backer, M.D., M.S.	University Hospital of Antwerp

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	FLUIDDA nv
ClinicalTrials.gov Identifier:	NCT02441413 History of Changes
Other Study ID Numbers:	FLUI-2014-103_BE
First Posted:	May 12, 2015
Last Update Posted:	March 29, 2017
Last Verified:	February 2016

Keywords provided by FLUIDDA nv:

HRCT; High Resolution Computed Tomography scans; Functional Respiratory Imaging; FRI; Computed Tomography	CT; Bronchiolitis Obliterans Syndrome; BOS; Lung Transplant

Additional relevant MeSH terms:

Bronchiolitis; Bronchiolitis Obliterans; Bronchitis; Bronchial Diseases	Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Infections