Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-06 @ 1:09 PM
Study NCT ID:
NCT03044327
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2017-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Novel Non-invasive Inflammometry Following Lipopolysaccharide, Endotoxin (LPS) Challenge in Healthy Volunteers
Sponsor:
Fraunhofer-Institute of Toxicology and Experimental Medicine
Organization:
Study Overview
Official Title:
Development of Novel Non-invasive Inflammometry Following LPS Challenge in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to further profile and develop the Lipopolysaccharide, endotoxin (LPS) challenge models (both by instillation and inhalation) by investigating the utility of various non-invasive monitoring methods.
Detailed Description:
The hypothesis of the project is that local inflammatory changes in the lung induced by LPS can be captured by gas-enhanced Magnetic resonance imaging (MRI) and analysis of exhaled breath. While MRI is able to provide localized information on inflammatory processes, exhaled breath analysis can capture integral information over time. Assuming that these novel techniques correlate with cellular measures of inflammation, repetitive measurements to investigate onset and duration of action of investigational new drugs will be made possible.
The evaluation whether LPS induced changes in the lung can be captured and monitored by MRI will be performed by correlation of multiple endpoints describing the cellular composition of the airways with variables derived from MRI and breath analysis.
The evaluation whether LPS induced changes in the lung can be captured and monitored by MRI will be performed by correlation of multiple endpoints describing the cellular composition of the airways with variables derived from MRI and breath analysis.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: