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Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

Primary Purpose

Bronchiolitis Obliterans, Lung Transplant Rejection

Status
Terminated
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
HRCT scans
Sponsored by
FLUIDDA nv
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchiolitis Obliterans focused on measuring HRCT, High Resolution Computed Tomography scans, Functional Respiratory Imaging, FRI, Computed Tomography, CT, Bronchiolitis Obliterans Syndrome, BOS, Lung Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

  • Pregnant or lactating female
  • Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation

Sites / Locations

  • Antwerp University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HRCT scans

Arm Description

High Resolution Computed Tomography scans will be taken

Outcomes

Primary Outcome Measures

Change in Airway Volume (iVaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
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.
Change in Specific Airway Volume (siVaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Specific Airway Resistance (siRaw) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Lobe Volumes (iVlobes) using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
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.
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).
Change in Low Attenuation or Emphysema Score using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Blood Vessel Density or Fibrosis Score using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Change in Airway Wall Thickness using FRI
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2015
Last Updated
March 19, 2018
Sponsor
FLUIDDA nv
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1. Study Identification

Unique Protocol Identification Number
NCT02488304
Brief Title
Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)
Official Title
Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
the lung transplantation program at the site is on hold
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FLUIDDA nv

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HRCT scans
Arm Type
Experimental
Arm Description
High Resolution Computed Tomography scans will be taken
Intervention Type
Radiation
Intervention Name(s)
HRCT scans
Other Intervention Name(s)
High Resolution Computed Tomography scans
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Airway Volume (iVaw) using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Time Frame
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Title
Change in Airway Resistance (iRaw) using FRI
Description
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.
Time Frame
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Title
Change in Specific Airway Volume (siVaw) using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Time Frame
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Title
Change in Specific Airway Resistance (siRaw) using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Time Frame
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Title
Change in Lobe Volumes (iVlobes) using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Time Frame
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Title
Change in Air trapping using FRI
Description
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.
Time Frame
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Title
Change in Internal Lobar Airflow Distribution using FRI
Description
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).
Time Frame
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Title
Change in Low Attenuation or Emphysema Score using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Time Frame
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Title
Change in Blood Vessel Density or Fibrosis Score using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Time Frame
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant
Title
Change in Airway Wall Thickness using FRI
Description
Exploratory imaging endpoints: HRCT scan will be taken at visit 2- visit 7.
Time Frame
3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried De Backer, M.D., M.S.
Organizational Affiliation
University Hospital of Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

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Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

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