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Transplant Optimization Using Functional Imaging (TROFI)

Primary Purpose

Bronchiolitis Obliterans, Lung Transplant Rejection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Resolution Computed Tomography scan
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, 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
  • 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

Sites / Locations

  • Columbia University Medical Center
  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HRCT scans

Arm Description

HRCT scan will be taken

Outcomes

Primary Outcome Measures

Airway Volume (iVaw)
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Airway Resistance (iRaw)
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Specific Airway Volume (siVaw)
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Specific Airway Resistance (siRaw)
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Lobe volumes (iVlobes)
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Air trapping
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Internal Lobar Airflow Distribution
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Low Attenuation or Emphysema Score
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Blood Vessel Density or Fibrosis Score
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Airway Wall Thickness
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2015
Last Updated
March 28, 2017
Sponsor
FLUIDDA nv
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1. Study Identification

Unique Protocol Identification Number
NCT02364674
Brief Title
Transplant Optimization Using Functional Imaging
Acronym
TROFI
Official Title
Transplant Optimization Using Functional Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 9, 2017 (Actual)
Study Completion Date
January 9, 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 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.

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, BOS, Lung Transplant

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HRCT scans
Arm Type
Experimental
Arm Description
HRCT scan will be taken
Intervention Type
Radiation
Intervention Name(s)
High Resolution Computed Tomography scan
Other Intervention Name(s)
HRCT scan
Intervention Description
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 Outcome Measure Information:
Title
Airway Volume (iVaw)
Description
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Time Frame
12 months
Title
Airway Resistance (iRaw)
Description
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Time Frame
12 months
Title
Specific Airway Volume (siVaw)
Description
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Time Frame
12 months
Title
Specific Airway Resistance (siRaw)
Description
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Time Frame
12 months
Title
Lobe volumes (iVlobes)
Description
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Time Frame
12 months
Title
Air trapping
Description
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Time Frame
12 months
Title
Internal Lobar Airflow Distribution
Description
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Time Frame
12 months
Title
Low Attenuation or Emphysema Score
Description
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Time Frame
12 months
Title
Blood Vessel Density or Fibrosis Score
Description
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Time Frame
12 months
Title
Airway Wall Thickness
Description
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Time Frame
12 months

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Lederer, M.D., M.S.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Lee, M.D., M.S.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Gibson
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Transplant Optimization Using Functional Imaging

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