Imaging of Peri-operative (periOP) Lung Injury

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-11

Study Completion Date

2020-02-05

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Acute Lung Injury Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

SPECT-CT imaging

Intervention Type RADIATION

Injection of AxV-128 labeled with 99mTc followed by SPECT CT

AxV-128/Tc

Intervention Type DRUG

Injection of AxV-128 labeled with 99mTc

Whipple procedure

Intervention Type 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

Intervention Type PROCEDURE

Additional surgical procedure(s) that is clinically indicated. Standard of care.

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).

Group Type OTHER

SPECT-CT imaging

Intervention Type RADIATION

Injection of AxV-128 labeled with 99mTc followed by SPECT CT

AxV-128/Tc

Intervention Type DRUG

Injection of AxV-128 labeled with 99mTc

Whipple procedure

Intervention Type 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

Intervention Type PROCEDURE

Additional surgical procedure(s) that is clinically indicated. Standard of care.

Interventions

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SPECT-CT imaging

Injection of AxV-128 labeled with 99mTc followed by SPECT CT

Intervention Type RADIATION

AxV-128/Tc

Injection of AxV-128 labeled with 99mTc

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Major surgery

Additional surgical procedure(s) that is clinically indicated. Standard of care.

Intervention Type PROCEDURE

Other Intervention Names

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SPECT CT 99mTc-rhAnnexin V-128 Pancreaticoduodenectomy Surgical procedure

Eligibility Criteria

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Inclusion Criteria

* 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