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Completed

NCT Number: NCT02441413

Transplant Optimization Using Functional Imaging (TROFI)

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.

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Key information

Conditions

Bronchiolitis Obliterans Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Lung Transplant Rejection Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Resolution Computed Tomography scans

Radiation

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

FLUIDDA nv

Industry

Registry information

Acronym: TROFI_BE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 12, 2015
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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