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18F-Fluciclovine PET/CT Scan for Pancreatic Transplant Assessment
Phase < 1
Waitlist Available
Led By Jeffrey Yap, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 or over in age
Have any type of pancreatic transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this outcome will be measured after the radiologic images have been processed and archived (within 24 hours of intervention) and laboratory results are certified (within 24 hours of intervention).
Awards & highlights
Study Summary
This trial will test whether 18F-Fluciclovine PET/CT can accurately diagnose and assess pancreatic allograft viability and rejection risk.
Who is the study for?
This trial is for individuals aged 18 or older who have had any type of pancreatic transplant and can consent to a PET/CT scan. It's specifically not for patients with known prostate cancer, and only non-diabetic patients' scans will be reviewed if they're from the archive.Check my eligibility
What is being tested?
The study is testing whether a special imaging agent called 18F-Fluciclovine used in PET/CT scans can accurately identify and assess the health of pancreatic transplants, as well as predict the risk of transplant rejection by measuring its function.See study design
What are the potential side effects?
While specific side effects are not listed here, generally PET/CT scans may cause discomfort at injection site, allergic reactions to tracers, or anxiety during scanning. However, most people tolerate these procedures without significant issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ this outcome will be measured after the radiologic images have been processed and archived (within 24 hours of intervention) and laboratory results are certified (within 24 hours of intervention).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this outcome will be measured after the radiologic images have been processed and archived (within 24 hours of intervention) and laboratory results are certified (within 24 hours of intervention).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Transplantation, Homologous
Measurement of Pancreatic Allograft Viability after 18F-Fluciclovine Utilization
Measurement of Pancreatic Allograft Visibility after 18F-Fluciclovine Utilization
Trial Design
1Treatment groups
Experimental Treatment
Group I: 18F fluciclovine AdministrationExperimental Treatment1 Intervention
Initial normal standardized uptake values (SUV) of the pancreas, liver, and blood pool will be obtained from 50archived previous 18F-Fluciclovine studies, as there are no normal ranges in the literature. This will be done by retrospective medical record review after a waiver of consent/authorization is obtained from the local IRB.
Informed consent will be obtained from 10 patients with pancreatic allografts, and each will undergo an 18F-Fluciclovine study. These patients will not be suspected of having current rejection or allograft dysfunction. Timing of 18F-Fluciclovine PET/CT scans will be planned to coincide with standard-of-care imaging studies and laboratory tests.
The 18F-Fluciclovine study will be compared with the patients' standard-standard-of-care US and/or CT with the assessment of ease of visualization of the pancreatic allograft.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluciclovine (18F)
FDA approved
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,089 Previous Clinical Trials
1,728,381 Total Patients Enrolled
2 Trials studying Pancreatitis
116 Patients Enrolled for Pancreatitis
Jeffrey Yap, PhDPrincipal InvestigatorUniversity of Utah
Frequently Asked Questions
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