Transplant Optimization Using Functional Imaging

NCT ID: NCT02364674

Last Updated: 2017-03-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-01-09

Brief Summary

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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

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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

HRCT scan will be taken

Group Type EXPERIMENTAL

High Resolution Computed Tomography scan

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Other Intervention Names

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HRCT scan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FLUIDDA nv

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Lederer, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

James Lee, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Hospital of the University of Pennsylvania

Gibson, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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FLUI-2014-103_USA

Identifier Type: -

Identifier Source: org_study_id

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