Acute Lung InjuryPhase 2NCT02978885
Imaging of Peri-operative (periOP) Lung Injury
A Phase 2 study testing SPECT-CT imaging, AxV-128/Tc and Whipple procedure in people with Acute Lung Injury and Chronic Obstructive Pulmonary Disease (COPD), run by Columbia University at 1 site in United States.
Trial summary
The aim of study is to determine if 99mTc Annexin V-128 (AxV- 128/Tc) single photon emission computed tomography (SPECT)-computed tomography (CT) can detect perioperative lung injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- SPECT-CT imaging, AxV-128/Tc and Whipple procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 5 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients with moderate COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II: forced expiratory volume 1 (FEV1)/forced vital capacity (FVC) <0.70 and FEV1 50-79% normal) undergoing Whipple procedures or other major surgeries
- Patients with normal lung function undergoing Whipple procedures or other major abdominal surgeries
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: In Vivo Imaging of Peri-operative (periOP) Destructive Processes in the Lung
The aim of study is to determine if 99mTc Annexin V-128 (AxV- 128/Tc) single photon emission computed tomography (SPECT)-computed tomography (CT) can detect perioperative lung injury. The investigators will study patients undergoing major surgery, specifically Whipple procedures (pancreatico-duodenectomies) and compare AxV-128/Tc SPECT-CT scans before and after surgery in Chronic Obstructive Pulmonary Disease (COPD) and non-COPD patients.
Read the detailed description
Lung injury is commonly not detected unless structural damage has occurred. SPECT-CT scanning using a specific tracer that lights up when it detects apoptosis (programmed cell death) has been used to detect even minor lung injury for example by smoke inhalation in animals and may be more sensitive to detect a less severe injury. The present study aims to study SPECT-CT scan using a tracer for apoptosis, 99mTc Annexin V-128 (AxV- 128/Tc), to detect lung injury after major surgery. Prolonged ventilation during surgery can cause minor lung injury but is usually not clinically detected. The investigators are planning to study 40 patients (20 patients with pre-existing lung disease-COPD and 20 patients with normal preoperative lung function) who are undergoing Whipple operations or other major surgery. The investigators will obtain SPECT-CT scans before and then 2-3 days after surgery and compare the uptake of a radioactive tracer with plasma markers of lung injury (Soluble Receptors for Advanced Glycation End Products (sRAGE), Interleukin 6 (IL-6), Clara-cell 16 and lung surfactant protein D (SP-D) among others). The investigators will ask the subjects to undergo spirometry testing, blood draws and urine collection. In addition, a SPECT-CT scan that lasts approximately 1 hour will be performed prior to surgery and 2-3 days post-operatively (while still hospitalized).
The total effective dose from the combined SPECT and CT scans is 6.2 millisievert (mSv). This effective dose is below what a patient receives during a standard 2 dose rest and stress cardiac nuclear imaging study and well within the range of current clinical nuclear imaging tests. The exact long term risk for development of cancer from diagnostic radiological procedures is currently under debate but all imaging procedures in this study are aimed to keep total radiation burden As Low As Reasonably Achievable (ALARA).
- Being tested
- SPECT-CT imaging, AxV-128/Tc, Whipple procedure, Major surgery
- Keywords
- Acute lung injury, Chronic obstructive pulmonary disease (COPD), Whipple procedures, pancreatico-duodenectomies
- Medical subject headings
- Acute Lung Injury, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT-CT imagingRadiation
Also called SPECT CT
Injection of AxV-128 labeled with 99mTc followed by SPECT CT
AxV-128/TcDrug
Also called 99mTc-rhAnnexin V-128
Injection of AxV-128 labeled with 99mTc
Whipple procedureProcedure or surgery
Also called Pancreaticoduodenectomy
A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.
Major surgeryProcedure or surgery
Also called Surgical procedure
Additional surgical procedure(s) that is clinically indicated. Standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Normal preoperative lung function | Other | Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging). Receives: Radiation: SPECT-CT imaging; Drug: AxV-128/Tc; Procedure: Whipple procedure; Procedure: Major surgery |
| Preoperative COPD | Other | Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging). Receives: Radiation: SPECT-CT imaging; Drug: AxV-128/Tc; Procedure: Whipple procedure; Procedure: Major surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of AxV-128/Tc Uptake and Fibrinogen
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Measured: Up to 1 week from initial scan
Correlation of AxV-128/Tc Uptake and C-Reactive Protein (CRP)
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Measured: Up to 1 week from initial scan
Correlation of AxV-128/Tc Uptake and White Blood Cell (WBC) Count
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Measured: Up to 1 week from initial scan
Secondary outcomes (5)
AxV-128/Tc Uptake
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Measured: Up to 1 week from initial scan
Correlation of AxV-128/Tc Uptake and RAGE
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Measured: Up to 1 week from initial scan
Correlation of AxV-128/Tc Uptake and IL-6
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Measured: Up to 1 week from initial scan
Correlation of AxV-128/Tc Uptake and Clara-cell 16
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Measured: Up to 1 week from initial scan
Correlation of AxV-128/Tc Uptake and SP-D
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Measured: Up to 1 week from initial scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start11 Jun 2018
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gebhard Wagener, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978885
- Sponsor's protocol ID
- AAAR0395
- Other IDs
- 1R01HL131960-01
- Status last verified
- Aug 2021
- First submitted
- 28 Nov 2016
- Last updated
- 14 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Imaging of Peri-operative (periOP) Destructive Processes in the Lung
- ClinicalTrials.gov ID
- NCT02978885
- Acronym / sponsor ID
- AAAR0395
- Keywords
- Acute lung injury, Chronic obstructive pulmonary disease (COPD), Whipple procedures, pancreatico-duodenectomies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Posted 14 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of study is to determine if 99mTc Annexin V-128 (AxV- 128/Tc) single photon emission computed tomography (SPECT)-computed tomography (CT) can detect perioperative lung injury. The investigators will study patients undergoing major surgery, specifically Whipple procedures (pancreatico-duodenectomies) and compare AxV-128/Tc SPECT-CT scans before and after surgery in Chronic Obstructive Pulmonary Disease (COPD) and non-COPD patients.
Detailed description
Lung injury is commonly not detected unless structural damage has occurred. SPECT-CT scanning using a specific tracer that lights up when it detects apoptosis (programmed cell death) has been used to detect even minor lung injury for example by smoke inhalation in animals and may be more sensitive to detect a less severe injury. The present study aims to study SPECT-CT scan using a tracer for apoptosis, 99mTc Annexin V-128 (AxV- 128/Tc), to detect lung injury after major surgery. Prolonged ventilation during surgery can cause minor lung injury but is usually not clinically detected. The investigators are planning to study 40 patients (20 patients with pre-existing lung disease-COPD and 20 patients with normal preoperative lung function) who are undergoing Whipple operations or other major surgery. The investigators will obtain SPECT-CT scans before and then 2-3 days after surgery and compare the uptake of a radioactive tracer with plasma markers of lung injury (Soluble Receptors for Advanced Glycation End Products (sRAGE), Interleukin 6 (IL-6), Clara-cell 16 and lung surfactant protein D (SP-D) among others). The investigators will ask the subjects to undergo spirometry testing, blood draws and urine collection. In addition, a SPECT-CT scan that lasts approximately 1 hour will be performed prior to surgery and 2-3 days post-operatively (while still hospitalized).
The total effective dose from the combined SPECT and CT scans is 6.2 millisievert (mSv). This effective dose is below what a patient receives during a standard 2 dose rest and stress cardiac nuclear imaging study and well within the range of current clinical nuclear imaging tests. The exact long term risk for development of cancer from diagnostic radiological procedures is currently under debate but all imaging procedures in this study are aimed to keep total radiation burden As Low As Reasonably Achievable (ALARA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal preoperative lung function | Other | Radiation: SPECT-CT imaging, Drug: AxV-128/Tc, Procedure: Whipple procedure, Procedure: Major surgeryPatients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging). |
| Preoperative COPD | Other | Radiation: SPECT-CT imaging, Drug: AxV-128/Tc, Procedure: Whipple procedure, Procedure: Major surgeryPatients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with moderate COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II: forced expiratory volume 1 (FEV1)/forced vital capacity (FVC) <0.70 and FEV1 50-79% normal) undergoing Whipple procedures or other major surgeries
- Patients with normal lung function undergoing Whipple procedures or other major abdominal surgeries
Key exclusion criteria (1 listed)
- Age < 18 years
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 |
|---|---|---|
| SPECT-CT imagingAlso: SPECT CTInjection of AxV-128 labeled with 99mTc followed by SPECT CT | Radiation | Normal preoperative lung function, Preoperative COPD |
| AxV-128/TcAlso: 99mTc-rhAnnexin V-128Injection of AxV-128 labeled with 99mTc | Drug | Normal preoperative lung function, Preoperative COPD |
| Whipple procedureAlso: PancreaticoduodenectomyA Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct. The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care. | Procedure or surgery | Normal preoperative lung function, Preoperative COPD |
| Major surgeryAlso: Surgical procedureAdditional surgical procedure(s) that is clinically indicated. Standard of care. | Procedure or surgery | Normal preoperative lung function, Preoperative COPD |
Primary outcome
Correlation of AxV-128/Tc Uptake and Fibrinogen
Time frame: Up to 1 week from initial scan
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Correlation of AxV-128/Tc Uptake and C-Reactive Protein (CRP)
Time frame: Up to 1 week from initial scan
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Correlation of AxV-128/Tc Uptake and White Blood Cell (WBC) Count
Time frame: Up to 1 week from initial scan
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
5 secondary outcomes
AxV-128/Tc Uptake
Time frame: Up to 1 week from initial scan
Correlation of AxV-128/Tc Uptake and RAGE
Time frame: Up to 1 week from initial scan
Correlation of AxV-128/Tc Uptake and IL-6
Time frame: Up to 1 week from initial scan
Correlation of AxV-128/Tc Uptake and Clara-cell 16
Time frame: Up to 1 week from initial scan
Correlation of AxV-128/Tc Uptake and SP-D
Time frame: Up to 1 week from initial scan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Gebhard Wagener, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPECT-CT imaging, AxV-128/Tc and Whipple procedure in people with Acute Lung Injury and Chronic Obstructive Pulmonary Disease (COPD), run by Columbia University 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 14 Sep 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Correlation of AxV-128/Tc Uptake and Fibrinogen (time frame: Up to 1 week from initial scan). The study lists 3 primary outcomes in all. 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 14 Sep 2021.