Positron Emission Tomography Assessment of Acute Lung Transplant Rejection
Overview
- Phase
- Not Applicable
- Intervention
- [18F]FDG
- Conditions
- Lung Disease
- Sponsor
- Washington University School of Medicine
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Ki, the influx constant that describes the rate of [18F]FDG uptake, in the whole lung
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Double-lung transplant recipient
- •Scheduled for bronchoscopy with transbronchial biopsy
- •Capable of lying still and supine with arms raised above the head within the PET/CT scanner for \~1.25 hours
- •Capable of following instructions for breathing protocol during CT portion of PET/CT
- •Able and willing to give informed consent
- •BMI \< 35
- •Already scheduled to undergo bronchoscopy with bronchoalveolar lavage (BAL) for clinical reasons
- •Willing to donate a portion of BAL and biopsy specimen for laboratory testing
Exclusion Criteria
- •Glucose level \> 150 mg/dl at time of \[18F\]FDG PET scan (however, up to 160 mg/dl, with repeat testing showing level is stable or decreasing, is acceptable)
- •Pregnancy (confirmed by qualitative urine human chorionic gonadotropin (hCG) pregnancy test)
- •Lactation
- •Presence of implanted electronic medical device
- •Enrollment in another research study of an investigational drug
- •Inability to lie flat with arms raised above the head for 1.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT
Arms & Interventions
Grade A0
Double-lung transplant recipients with no evidence of rejection who undergo both \[18F\]FDG and \[18F\]ISO-1 PET imaging scans
Intervention: [18F]FDG
Grade A0
Double-lung transplant recipients with no evidence of rejection who undergo both \[18F\]FDG and \[18F\]ISO-1 PET imaging scans
Intervention: [18F]ISO-1
Grades A2-3
Double-lung transplant recipients with mild to moderate rejection who undergo both \[18F\]FDG and \[18F\]ISO-1 PET imaging scans
Intervention: [18F]FDG
Grades A2-3
Double-lung transplant recipients with mild to moderate rejection who undergo both \[18F\]FDG and \[18F\]ISO-1 PET imaging scans
Intervention: [18F]ISO-1
Outcomes
Primary Outcomes
Ki, the influx constant that describes the rate of [18F]FDG uptake, in the whole lung
Time Frame: This outcome measure is assessed from the [18F]FDG scan performed on Day 1.
Logan plot analysis determined distribution volume ratio (DVR) of [18F] ISO-1 uptake
Time Frame: This outcome measure is assessed from the [18F]ISO-1 PET scan performed on Day 2.
Secondary Outcomes
- Progesterone receptor membrane component 1 (PGRMC1) staining of biopsy tissues and bronchoalveolar lavage cells(Assessed after the baseline clinical bronchoscopy procedure is performed 3 days prior to FDG PET/CT scan)