Imaging of Peri-operative (periOP) Lung Injury

NCT02978885 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: AAAR03951R01HL131960-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Lung Injury; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Acute lung injury; Chronic obstructive pulmonary disease (COPD); Whipple procedures; pancreatico-duodenectomies

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Up to 1 week from initial scan

Secondary Outcomes (5)

• AxV-128/Tc Uptake

  Up to 1 week from initial scan

• Correlation of AxV-128/Tc Uptake and RAGE

  Up to 1 week from initial scan

• Correlation of AxV-128/Tc Uptake and IL-6

  Up to 1 week from initial scan

• Correlation of AxV-128/Tc Uptake and Clara-cell 16

  Up to 1 week from initial scan

• Correlation of AxV-128/Tc Uptake and SP-D

  Up to 1 week from initial scan

Study Arms (2)

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).

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).

Radiation: SPECT-CT imaging; Drug: AxV-128/Tc; Procedure: Whipple procedure; Procedure: Major surgery

Interventions

SPECT-CT imaging RADIATION

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

Also known as: SPECT CT

Normal preoperative lung function; Preoperative COPD

AxV-128/Tc DRUG

Injection of AxV-128 labeled with 99mTc

Also known as: 99mTc-rhAnnexin V-128

Normal preoperative lung function; Preoperative COPD

Whipple procedure 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.

Also known as: Pancreaticoduodenectomy

Normal preoperative lung function; Preoperative COPD

Major surgery PROCEDURE

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

Also known as: Surgical procedure

Normal preoperative lung function; Preoperative COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Acute Lung Injury; Pulmonary Disease, Chronic Obstructive

Interventions

Pancreaticoduodenectomy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures

Limitations and Caveats

Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).

Results Point of Contact

• Title: Gebhard Wagener, MD
• Organization: Columbia University

gw72@cumc.columbia.edu

212-305-6494

Study Officials

• Gebhard Wagener, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 1, 2016
• Study Start: June 11, 2018
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: September 14, 2021
• Results First Posted: September 14, 2021

Record last verified: 2021-08

Locations

US (1)