Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Bronchiolitis Obliterans Lung Transplant Rejection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HRCT scans

High Resolution Computed Tomography scans will be taken

Group Type EXPERIMENTAL

HRCT scans

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Other Intervention Names

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High Resolution Computed Tomography scans

Eligibility Criteria

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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