Transplant Optimization Using Functional Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Low Attenuation or Emphysema Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HRCT scans
HRCT scan will be taken
Intervention: High Resolution Computed Tomography scan (Radiation)
Outcomes
Primary Outcomes
Low Attenuation or Emphysema Score
Time Frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Airway Wall Thickness
Time Frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Lobe volumes (iVlobes)
Time Frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Specific Airway Resistance (siRaw)
Time Frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Airway Volume (iVaw)
Time Frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Blood Vessel Density or Fibrosis Score
Time Frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Internal Lobar Airflow Distribution
Time Frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Airway Resistance (iRaw)
Time Frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Specific Airway Volume (siVaw)
Time Frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Air trapping
Time Frame: 12 months
Exploratory imaging endpoints: HRCT-scan will be taken at visit 1 - visit 5.
Secondary Outcomes
No secondary outcomes reported