NCT02488304|TerminatedPhase 2
Study Stopped
the lung transplantation program at the site is on hold
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Sponsor study identifier
interventional
10
1 country
1
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 15, 2017
Actual (reported)Study Completion
December 15, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 26, 2015
Actual (reported)July 2015
Date type not reportedThis date has not been verified as actual or estimated.
July 2, 2015
Actual (reported)December 15, 2017
Actual (reported)December 15, 2017
Actual (reported)Change in Airway Volume (iVaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Airway Resistance (iRaw) using FRI
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.
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Specific Airway Volume (siVaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
High Resolution Computed Tomography scans will be taken
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Antwerp University Hospital
Edegem, Antwerp, 2650, Belgium
Wilfried De Backer, M.D., M.S.
University Hospital of Antwerp
10 participants (actual enrollment reported by the registry).
First Submitted
June 26, 2015
First Posted
July 2, 2015
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Targeted Therapy of Bronchiolitis Obliterans Syndrome
Change in Specific Airway Resistance (siRaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Lobe Volumes (iVlobes) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Air trapping using FRI
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.
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Internal Lobar Airflow Distribution using FRI
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).
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Low Attenuation or Emphysema Score using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Blood Vessel Density or Fibrosis Score using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Change in Airway Wall Thickness using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Contact the study team to confirm eligibility.
Primary Completion
December 15, 2017
Actual (reported)Study Completion
December 15, 2017
Actual (reported)Last Updated
March 21, 2018
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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