Transplant Optimization Using Functional Imaging

Not Applicable

Completed

• Conditions: Bronchiolitis Obliterans; Lung Transplant Rejection
• Interventions: Radiation: High Resolution Computed Tomography scan

• Registration Number: NCT02364674
• Lead Sponsor: FLUIDDA nv

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-18
• Status Verified: 2016-02
• Primary Completion: 2017-01-09
• Study Completion: 2017-01-09
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRCT scans	High Resolution Computed Tomography scan	HRCT scan will be taken

Primary Outcome Measures

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

Trial Locations

Locations (2)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Hospital of the University of Pennsylvania; 🇺🇸 Gibson, Pennsylvania, United States