Overview

This trial is active, not recruiting.

Conditions bronchiolitis obliterans, lung transplant rejection
Treatment high resolution computed tomography scan
Sponsor FLUIDDA nv
Start date February 2015
End date March 2017
Trial size 8 participants
Trial identifier NCT02364674, FLUI-2014-103_USA

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 non-rigid image registration methods.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
HRCT scan will be taken
high resolution computed tomography scan HRCT scan
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.

Primary Outcomes

Measure
Airway Volume (iVaw)
time frame: 12 months
Airway Resistance (iRaw)
time frame: 12 months
Specific Airway Volume (siVaw)
time frame: 12 months
Specific Airway Resistance (siRaw)
time frame: 12 months
Lobe volumes (iVlobes)
time frame: 12 months
Air trapping
time frame: 12 months
Internal Lobar Airflow Distribution
time frame: 12 months
Low Attenuation or Emphysema Score
time frame: 12 months
Blood Vessel Density or Fibrosis Score
time frame: 12 months
Airway Wall Thickness
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 visit 1 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

Additional Information

Official title Transplant Optimization Using Functional Imaging
Principal investigator David Lederer, M.D., M.S.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by FLUIDDA nv.