Clinical Trials Directory

Trials / Terminated

TerminatedNCT02204202

PET Assessment of Acute Lung Transplant Rejection

Positron Emission Tomography Assessment of Acute Lung Transplant Rejection

Status
Terminated
Phase
Study type
Observational
Enrollment
28 (actual)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

The purpose of this research study is to gain understanding of the basic responses of the lungs to inflammation and specifically if there may be a better way to detect graft inflammation using non-invasive methods as well as to determine the effectiveness of immunosuppressive treatment regimens in preventing acute rejection in lung transplant recipients.

Detailed description

Positron emission tomography with fluorodeoxyglucose (FDG-PET) is a potential way we can measure lung inflammation. FDG-PET imaging is a clinically accepted and FDA-approved method that is commonly used in the diagnosis and management of cancer. PET is a machine that detects radiation and generates pictures using a donut shaped scanner similar in appearance to an x-ray "CAT" computerized axial tomography or computed tomography (CT) scan. FDG stands for \[18F\] (flourine 18) fluorodeoxyglucose, a radiolabeled sugar that is used to identify areas of inflammation with the PET scanner. A CT scan takes a picture of what the lungs and airways look like. T cells are the primary cause of acute rejection of lung transplants. Because T cells must divide in order to be activated and cause rejection, imaging them while they are dividing is another way that we can determine whether acute rejection is occurring. A new PET tracer called \[18F\]ISO-1 (18F-labeled σ2-receptor ligand for PET, N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-18F-fluoroethoxy)-5-methylbenzamide (18F-3c), binds to dividing cells. Therefore, \[18F\]ISO-1 may help us measure acute rejection more accurately. \[18F\]ISO-1 is an investigational drug.

Conditions

Interventions

TypeNameDescription
DRUG[18F]FDG10 millicuries (mCi) of \[18F\]FDG will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition
DRUG[18F]ISO-18 mCi of \[18F\]ISO-1 will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition

Timeline

Start date
2014-02-01
Primary completion
2017-02-04
Completion
2017-02-04
First posted
2014-07-30
Last updated
2020-10-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02204202. Inclusion in this directory is not an endorsement.