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Transplant Optimization Using Functional Imaging (TROFI) (TROFI_BE)

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ClinicalTrials.gov Identifier: NCT02441413
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
FLUIDDA nv

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

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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441413


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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Responsible Party: FLUIDDA nv
ClinicalTrials.gov Identifier: NCT02441413     History of Changes
Other Study ID Numbers: FLUI-2014-103_BE
First Posted: May 12, 2015    Key Record Dates
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