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Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

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ClinicalTrials.gov Identifier: NCT02488304
Recruitment Status : Terminated (the lung transplantation program at the site is on hold)
First Posted : July 2, 2015
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
FLUIDDA nv

June 26, 2015
July 2, 2015
March 21, 2018
July 2015
December 15, 2017   (Final data collection date for primary outcome measure)
  • Change in Airway Volume (iVaw) using FRI [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
  • Change in Airway Resistance (iRaw) using FRI [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airway resistance is defined as the pressure drop over the airways divided by the airflow.
  • Change in Specific Airway Volume (siVaw) using FRI [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
  • Change in Specific Airway Resistance (siRaw) using FRI [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
  • Change in Lobe Volumes (iVlobes) using FRI [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
  • Change in Air trapping using FRI [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Air trapping is defined as the regions in the lung with a gray value on the CT-scan image smaller than −850 HU at functional residual capacity.
  • Change in Internal Lobar Airflow Distribution using FRI [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7. Airflow distribution is defined in as the percentage of air going to every lobe when inhaling from FRC to TLC and is calculated for every lobe as: IALDlobe [%] = 100 (VTLC_lobe - VFRC_lobe) / (VTLC_lungs - VFRC_lungs).
  • Change in Low Attenuation or Emphysema Score using FRI [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
  • Change in Blood Vessel Density or Fibrosis Score using FRI [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
  • Change in Airway Wall Thickness using FRI [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant ]
    Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Same as current
Complete list of historical versions of study NCT02488304 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)
Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)
The objective of this study is to detect BOS in an early stage by 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 rejection over time will be monitored using non-rigid image registration methods.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Bronchiolitis Obliterans
  • Lung Transplant Rejection
Radiation: HRCT scans

A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 2, visit 3, visit 4, visit 5, visit 6, and visit 7.

An upper airway (UA) scan will be taken on visit 2.

Other Name: High Resolution Computed Tomography scans
Experimental: HRCT scans
High Resolution Computed Tomography scans will be taken
Intervention: Radiation: HRCT scans
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
Same as current
December 15, 2017
December 15, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patient ≥ 18 years old
  • Written informed consent obtained
  • Patients who are planned to receive a lung transplant in the near future
  • 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

Exclusion Criteria:

  • Pregnant or lactating female
  • Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02488304
FLUI-2015-141
No
Not Provided
Not Provided
FLUIDDA nv
FLUIDDA nv
Not Provided
Principal Investigator: Wilfried De Backer, M.D., M.S. University Hospital of Antwerp
FLUIDDA nv
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP