PET Imaging in Patients at Risk for Acute Lung Injury (PET-ALI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Fuller, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01486342
First received: November 21, 2011
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

Despite decades of research, the mortality in acute lung injury remains very high and treatment options are very limited. Given these facts, the best treatment modality may be in prevention of this lethal syndrome.

Historically, imaging has played a crucial role in understanding ALI. The appearance of chest radiography is one of the consensus criteria in defining ALI, and commuted tomography (CT) scans further advanced the understanding of the pathoanatomy of ALI. While valuable, these imaging modalities are nonspecific and do not incorporate functional cellular physiology.

PET imaging measures concentrations of radioisotopes in the body. By embedding in, but not altering molecules, the natural fate of these tracers can be studied with PET imaging. Advances in the understanding of ALI include blood flow distribution, as well as the response to alveolar recruitment maneuvers and prone positioning. Not all patients who are receiving mechanical ventilation develop ALI. Inflammation in the lungs is known to play a key early role in the development and progression of ALI. Secondary to inflammation, the lungs develop edema and do not exchange oxygen as well. This early inflammation is in part driven by a specific type of immune cell called the neutrophil. These cells seem to travel and become sequestered in the lung- they are "recruited" to the lung during this inflammatory stage. When there, these neutrophils release inflammatory substances which are integral in the development of ALI. Neutrophils use primarily glucose as a fuel source. The radio isotope [18F]Fluorodeoxyglucose (FDG)is a glucose analog and therefore taken up/ingested by the neutrophils as a part of their normal metabolism. Because of this fact, positron emission tomography (PET) using the radio isotope [18F]FDG is a highly sensitive marker to look at the recruitment of neutrophils to the lung, therefore quantifying the degree of pulmonary inflammation prior to the development of ALI.

The investigators seek to examine the relationship of pulmonary inflammation in patients at risk for ALI, but without clinical evidence of the syndrome. The investigators seek to enroll ten patients in a pilot trial.


Condition Intervention
Acute Lung Injury
Early Pulmonary Neutrophilic Inflammation
Radiation: PET-CT scan

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Positron Emission Tomography With [18F]Fluorodeoxyglucose in Patients at Risk for Acute Lung Injury

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The influx constant (Ki) of FDG uptake [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    The influx constant describes the rate of FDG uptake and represents pulmonary inflammation


Secondary Outcome Measures:
  • Correlation of the influx constant (Ki) with lung injury prediction score [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Mechanically ventilated patients without acute lung injury and lung injury prediction score < 4
Radiation: PET-CT scan

PET-CT imaging with [18F]FDG will be performed within 24 hours of admission to the ICU. All patients imaged will be those remaining on mechanical ventilation at the time of PET imaging.

A low-dose CT scan (50 effective mAs) will be obtained with placement of the participant such that the lungs are centered within the field of view. After completing the transmission scan, 10 mCi of [18F]FDG will be injected intravenously at the start of a 60-minute dynamic scan acquisition and the intravenous (IV) catheter flushed with 10 ml saline. Imaging will be obtained with the following framing schedule: 24 5-sec, 6 3-minute and 8 5-minute frames.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Mechanically ventilated patients without acute lung injury

Criteria

Inclusion Criteria:

  • Adults patients (age ≥ 18) presenting to the SICU after ≥ 5 hours of mechanical ventilation in the OR or ED, without clinical evidence of ALI, and LIPS > 4 or < 4.
  • Able to be positioned supine within the PET/CT scanner for ~1.25 hours
  • Has legally authorized representative (LAR) available and willing to give informed consent, or is able to give informed consent prior to initiation of mechanical ventilation
  • BMI < 35

Exclusion Criteria:

  • Established ALI by accepted clinical criteria.
  • Organ transplant recipient
  • Treatment with immunosuppressive/immune-modulating medications
  • Current corticosteroid treatment
  • Chronic pulmonary or nonpulmonary inflammatory diseases
  • Inability to safely travel out of the SICU (as established by regular safety screening criteria). Patient is placed in the supine position for a minimum of 30 minutes, and on mechanical ventilator settings that will be in place for the duration of the FDG-PET study. The patient is deemed unsafe for travel if oxygen requirement increases or any hemodynamic instability ensues (such as increasing vasopressor requirements).
  • Glucose level > 150 mg/dl at time of PET scan
  • Pregnancy (confirmed by qualitative urine hCG pregnancy test)
  • Lactation
  • Presence of implanted electronic medical device
  • Enrollment in another research study of an investigational drug
  • Prior research-related radiation exposure within the past year such that participation in this study would result in exposures that exceed the limits as defined by the FDA RDRC regulations (21 CFR 361.1)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486342

Locations
United States, Missouri
Washington University in St. Louis School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Brian Fuller, MD Washington University
  More Information

No publications provided

Responsible Party: Brian Fuller, Assistant Professor of Anesthesiology and Emergency Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01486342     History of Changes
Other Study ID Numbers: 201105122
Study First Received: November 21, 2011
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Wounds and Injuries
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries

ClinicalTrials.gov processed this record on April 22, 2014