TROFI: Transplant Optimization Using Functional Imaging
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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Outcome Measures
Primary Outcome Measures
- Airway Volume (iVaw) [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.
- Specific Airway Resistance (siRaw) [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.
- Air trapping [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.
- Blood Vessel Density or Fibrosis Score [12 months]
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
- Airway Wall Thickness [12 months]
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patient ≥ 18 years old
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Written informed consent obtained
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Patient who had undergone a lung transplant a year ago or more.
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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
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The patient must be able to perform the lung monitoring at home.
Exclusion Criteria:
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Pregnant or lactating female
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Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Columbia University Medical Center | New York | New York | United States | 10032 |
2 | Hospital of the University of Pennsylvania | Gibson | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- FLUI-2014-103_USA