NCT01407796

Brief Summary

The overall purpose of this research is to gain understanding of the basic responses of the lung to inflammation. Inflammation is the way our bodies react to irritation or injury, and involves red, warm, and often painful swelling of the affected tissue. "Acute lung injury" involves a generalized inflammation to the lung that is activated by any of several conditions: infection, trauma, inhalation of toxic substances, etc. When lung injury is severe, not enough oxygen can get into the body; this can lead to the need for mechanical support of breathing (mechanical ventilation), problems with brain, heart or other organ function, and in some cases, death. Inducible nitric oxide synthase (iNOS) contributes to the development of lung inflammation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

1.3 years

First QC Date

July 28, 2011

Last Update Submit

April 17, 2014

Conditions

Pneumonia

Keywords

lung inflammationpositron emission tomography (PET)fluorodeoxyglucose (FDG)inducible nitric oxide synthase (iNOS)lung anti-inflammatory therapy

Outcome Measures

Primary Outcomes (1)

  • Distribution volume ratio (DVR), determined by Logan plot analysis, in the right middle lobe.

    Change in DVR on post-endotoxin scan (Day 2) from baseline (Day 1).

Secondary Outcomes (2)

  • Bronchoalveolar lavage (BAL) fluid cell counts.

    24 hours after endotoxin instillation.

  • Number and percent of iNOS-stained BAL cells.

    24 hours after endotoxin instillation.

Study Arms (1)

Endotoxin and [18F](+/-)NOS

EXPERIMENTAL

All volunteers in this study will receive endotoxin in a single segment of the lung to induce mild, self-limited inflammation. They will also be imaged before and after endotoxin instillation with the novel PET tracer F-18 (+/-) NOS

Drug: Endotoxin (E. coli O:113, Reference Endotoxin)Drug: [18F](+/-)NOS

Interventions

Endotoxin (E. coli O:113, Reference Endotoxin)DRUG
Also known as: Lipopolysaccharide
Endotoxin and [18F](+/-)NOS
[18F](+/-)NOSDRUG
Endotoxin and [18F](+/-)NOS

Eligibility Criteria

Age19 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy man or woman, any race or ethnicity, age 19 - 44 years old
  • Screening Pulmonary Function Test
  • Screening oxygen saturation by pulse oximetry \>97% on room air
  • Capable of lying still and supine within the PET/CT scanner for 1.5 hours
  • Capable of following instructions for breathing protocol during CT portion of PET/CT
  • Able and willing to give informed consent
  • BMI \< 35

You may not qualify if:

  • Pregnancy (confirmed by qualitative serum hCG pregnancy test)
  • Lactation
  • Active menstruation
  • History of cardiopulmonary disease
  • Currently taking any prescription medications
  • History of tobacco use or illicit drug use within the past year
  • Presence of implanted electronic medical device
  • Enrollment in another research study of an investigational drug
  • Known allergy to both trimethoprim/sulfamethoxazole and amoxicillin
  • Known allergy to drugs routinely used during bronchoscopy
  • Inability lie flat for 1.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicne

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Huang HJ, Isakow W, Byers DE, Engle JT, Griffin EA, Kemp D, Brody SL, Gropler RJ, Miller JP, Chu W, Zhou D, Pierce RA, Castro M, Mach RH, Chen DL. Imaging pulmonary inducible nitric oxide synthase expression with PET. J Nucl Med. 2015 Jan;56(1):76-81. doi: 10.2967/jnumed.114.146381. Epub 2014 Dec 18.

    PMID: 25525182DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

EndotoxinsLipopolysaccharidesFluorine-18

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Bacterial ToxinsToxins, BiologicalBiological FactorsGlycoconjugatesCarbohydratesPolysaccharides, BacterialPolysaccharidesLipidsAntigens, BacterialAntigens

Study Officials

  • Delphine L. Chen, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Radiology

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 2, 2011

Study Start

December 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

US(1)