Transplant Optimization Using Functional Imaging (TROFI)

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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis Obliterans; Lung Transplant Rejection
• Intervention / Treatment: Radiation: High Resolution Computed Tomography scan

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Pennsylvania
    • Gibson, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

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
• 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

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; HRCT scan will be taken	Radiation: High Resolution Computed Tomography scan; 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.; Other Names: HRCT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway Volume (iVaw)	Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.	12 months
Airway Resistance (iRaw)	Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.	12 months
Specific Airway Volume (siVaw)	Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.	12 months
Specific Airway Resistance (siRaw)	Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.	12 months
Lobe volumes (iVlobes)	Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.	12 months
Air trapping	Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.	12 months
Internal Lobar Airflow Distribution	Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.	12 months
Low Attenuation or Emphysema Score	Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.	12 months
Blood Vessel Density or Fibrosis Score	Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.	12 months
Airway Wall Thickness	Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.	12 months

Collaborators and Investigators

• Sponsor: FLUIDDA nv
• Investigators: Principal Investigator: David Lederer, M.D., M.S., Columbia University; Principal Investigator: James Lee, M.D., M.S., University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 9, 2017
• Study Completion (Actual): January 9, 2017

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: CT; Computed Tomography; Bronchiolitis Obliterans; 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-2014-103_USA