Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

Sponsor

FLUIDDA nv (Industry)

Overall Status

Terminated

CT.gov ID

NCT02488304

Collaborator

(none)

Enrollment

Location

Arm

29.5

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans Lung Transplant Rejection	Radiation: HRCT scans	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Dec 15, 2017

Actual Study Completion Date :

Dec 15, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Airway Volume (iVaw) using FRI [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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