Bronchiolitis Obliterans Clinical Trial
— TROFI_BEOfficial title:
Transplant Optimization Using Functional Imaging (TROFI)
Verified date | February 2016 |
Source | FLUIDDA nv |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 nmon-rigid image registration methods.
Status | Completed |
Enrollment | 3 |
Est. completion date | November 8, 2016 |
Est. primary completion date | November 8, 2016 |
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 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 - Patients diagnosed with BOS 0, BOS 0-p or BOS 1 Exclusion Criteria: - Pregnant or lactating female - Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation |
Country | Name | City | State |
---|---|---|---|
Belgium | Antwerp University Hospital | Edegem | Antwerp |
Lead Sponsor | Collaborator |
---|---|
FLUIDDA nv |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Airway Volume (iVaw) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | |
Primary | Airway Resistance (iRaw) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | |
Primary | Specific Airway Volume (siVaw) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | |
Primary | Specific Airway Resistance (siRaw) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | |
Primary | Lobe Volumes (iVlobes) using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | |
Primary | Air Trapping using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | |
Primary | Internal Lobar Airflow Distribution using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | |
Primary | Low attenuation or Emphysema Score using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | |
Primary | Blood Vessel Density or Fibrosis Score using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months | |
Primary | Airway Wall Thickness using FRI | Exploratory imaging endpoints: HRCT scan will be taken at visit 1- visit 5. | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03603899 -
Hp129 Xenon Imaging and BOS in Lung Transplantation
|
Phase 1/Phase 2 | |
Recruiting |
NCT04098445 -
TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
|
||
Recruiting |
NCT02543073 -
MSC for Treatment of Interstitial Lung Disease After Allo-HSCT
|
Phase 1/Phase 2 | |
Terminated |
NCT01432080 -
Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
|
Phase 2 | |
Recruiting |
NCT00163696 -
Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease
|
N/A | |
Completed |
NCT00029328 -
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
|
Phase 1/Phase 2 | |
Terminated |
NCT01163786 -
A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD
|
Phase 2 | |
Recruiting |
NCT02627833 -
Lung Function, LCI, Bronchial Inflammation and Epigenetics of Patients With BO
|
N/A | |
Completed |
NCT01211509 -
Montelukast in Bronchiolitis Obliterans Syndrome
|
Phase 4 | |
Completed |
NCT01212406 -
Vitamin D in Bronchiolitis Obliterans Syndrome
|
Phase 4 | |
Completed |
NCT00701922 -
Surveillance Study of Viral Infections Following Lung Transplantation
|
N/A | |
Completed |
NCT00141726 -
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
|
Phase 2 | |
Recruiting |
NCT05922761 -
BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)
|
Phase 2 | |
Recruiting |
NCT05881538 -
High Intensity Intervallic Training in Children With Bronchiolitis Obliterans
|
N/A | |
Terminated |
NCT04655508 -
Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation
|
Phase 3 | |
Withdrawn |
NCT02109237 -
Sleep Disorders in Bronchiolitis Obliterans Syndrome 2&3
|
N/A | |
Completed |
NCT01327248 -
Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans
|
N/A | |
Recruiting |
NCT05932316 -
Evaluating Bronchodilator Response in Patients With Bronchiectasis
|
N/A | |
Active, not recruiting |
NCT03656926 -
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2)
|
Phase 3 | |
Completed |
NCT01206309 -
Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation
|
N/A |