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.

Study Overview

• Status: Terminated
• Conditions: Bronchiolitis Obliterans; Lung Transplant Rejection
• Intervention / Treatment: Radiation: HRCT scans

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRCT scans; High Resolution Computed Tomography scans will be taken	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 Names: High Resolution Computed Tomography scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: FLUIDDA nv

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: CT; Computed Tomography; Bronchiolitis Obliterans Syndrome; HRCT; High Resolution Computed Tomography scans; Functional Respiratory Imaging; FRI; BOS; Lung Transplant
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Bronchiolitis Obliterans
• Other Study ID Numbers: FLUI-2015-141