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
| Type | Name | Description |
|---|---|---|
| DRUG | [18F]FDG | 10 millicuries (mCi) of \[18F\]FDG will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition |
| DRUG | [18F]ISO-1 | 8 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.