Trial Outcomes & Findings for Imaging of Peri-operative (periOP) Lung Injury (NCT NCT02978885)
NCT ID: NCT02978885
Last Updated: 2021-09-14
Results Overview
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
TERMINATED
PHASE2
1 participants
Up to 1 week from initial scan
2021-09-14
Participant Flow
Participant milestones
| Measure |
Normal Preoperative Lung Function
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).
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc
Whipple procedure: 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 surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
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Preoperative COPD
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).
SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT
AxV-128/Tc: Injection of AxV-128 labeled with 99mTc
Whipple procedure: 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 surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
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Overall Study
STARTED
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0
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1
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Overall Study
COMPLETED
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0
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1
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imaging of Peri-operative (periOP) Lung Injury
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to 1 week from initial scanPopulation: Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 1 week from initial scanPopulation: Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 1 week from initial scanPopulation: Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 week from initial scanPopulation: Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 week from initial scanPopulation: Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 week from initial scanPopulation: Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 week from initial scanPopulation: Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 week from initial scanPopulation: Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Outcome measures
Outcome data not reported
Adverse Events
Normal Preoperative Lung Function
Preoperative COPD
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place