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Imaging of Peri-operative (periOP) Lung Injury

NCT02978885 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-09-14

Study results available
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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)

Interventions

RADIATION

SPECT-CT imaging

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

DRUG

AxV-128/Tc

Injection of AxV-128 labeled with 99mTc

PROCEDURE

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.

PROCEDURE

Major surgery

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Gebhard Wagener, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2020-02-05
Completion
2020-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02978885 on ClinicalTrials.gov