Acute Lung InjuryPET-ALINCT01486342
PET Imaging in Patients at Risk for Acute Lung Injury
An observational study of Acute Lung Injury and Early Pulmonary Neutrophilic Inflammation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Early Pulmonary Neutrophilic Inflammation
- What is being tested?
- PET-CT scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated patients without acute lung injury
Who may be able to join
- 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
Who cannot join
- 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).
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Positron Emission Tomography With [18F]Fluorodeoxyglucose in Patients at Risk for Acute Lung Injury
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.
Read more
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.
- Being tested
- PET-CT scan
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CT scanRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Mechanically ventilated patients without acute lung injury and lung injury prediction score < 4 Receives: Radiation: PET-CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The influx constant (Ki) of FDG uptake
The influx constant describes the rate of FDG uptake and represents pulmonary inflammation
Measured: 3 days
Secondary outcomes (1)
Correlation of the influx constant (Ki) with lung injury prediction score
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Fuller, Washington University School of Medicine
- Investigators
- Brian Fuller, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486342
- Sponsor's protocol ID
- 201105122
- Acronym
- PET-ALI
- Status last verified
- Jan 2013
- First submitted
- 21 Nov 2011
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography With [18F]Fluorodeoxyglucose in Patients at Risk for Acute Lung Injury
- ClinicalTrials.gov ID
- NCT01486342
- Acronym / sponsor ID
- PET-ALI / 201105122
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Radiation: PET-CT scanMechanically ventilated patients without acute lung injury and lung injury prediction score < 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients without acute lung injury
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Established ALI by accepted clinical criteria.
- Organ transplant recipient
- Treatment with immunosuppressive/immune-modulating medications
- Current corticosteroid treatment
- Chronic pulmonary or nonpulmonary inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-CT scanPET-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. | Radiation | Group 1 |
Primary outcome
The influx constant (Ki) of FDG uptake
Time frame: 3 days
The influx constant describes the rate of FDG uptake and represents pulmonary inflammation
1 secondary outcome
Correlation of the influx constant (Ki) with lung injury prediction score
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Fuller, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury and Early Pulmonary Neutrophilic Inflammation, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influx constant (Ki) of FDG uptake (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.