PET Assessment of Acute Lung Transplant Rejection
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 7/25/2018 |
| Start Date: | February 2014 |
| End Date: | May 2019 |
| Contact: | Delphine L Chen, MD |
| Email: | chend@mir.wustl.edu |
| Phone: | 314-362-7029 |
Positron Emission Tomography Assessment of Acute Lung Transplant Rejection
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.
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.
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-methylbe
nzamide (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.
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-methylbe
nzamide (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.
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
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: Delphine L Chen, MD
Phone: 314-362-7029
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