Status:
TERMINATED
PET Assessment of Acute Lung Transplant Rejection
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Lung Disease
Eligibility:
All Genders
19+ years
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-inv...
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 us...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 4 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02204202
Start Date
February 1 2014
End Date
February 4 2017
Last Update
October 8 2020
Active Locations (1)
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1
Washington University School of Medicine / Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110