Transplant Optimization Using Functional Imaging

Bronchiolitis Obliterans Clinical Trial

— TROFI  

Official title:

Transplant Optimization Using Functional Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364674
• Other study ID #: FLUI-2014-103_USA
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: March 28, 2017
• Start date: February 2015
• Est. completion date: January 9, 2017

Study information

• Verified date: February 2016
• Source: FLUIDDA nv
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 9, 2017
• Est. primary completion date: January 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Lung Transplant Rejection

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Gibson	Pennsylvania
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
FLUIDDA nv

Country where clinical trial is conducted

United States, 

Outcome

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