Clinical trial NCT02488304: Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)
Official title: Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bronchiolitis Obliterans
Lung Transplant Rejection
Keywords: HRCT
High Resolution Computed Tomography scans
Functional Respiratory Imaging
FRI
Computed Tomography
CT
Bronchiolitis Obliterans Syndrome
BOS
Lung Transplant
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Airway Volume (iVaw) using FRI
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
measure: Change in Airway Resistance (iRaw) using FRI
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
measure: Change in Specific Airway Volume (siVaw) using FRI
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
measure: Change in Specific Airway Resistance (siRaw) using FRI
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
measure: Change in Lobe Volumes (iVlobes) using FRI
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
measure: Change in Air trapping using FRI
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
measure: Change in Internal Lobar Airflow Distribution using FRI
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
measure: Change in Low Attenuation or Emphysema Score using FRI
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
measure: Change in Blood Vessel Density or Fibrosis Score using FRI
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
measure: Change in Airway Wall Thickness using FRI
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital of Antwerp
name: Wilfried De Backer, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: