18F-fluciclovine for Pancreatitis, Graft

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Utah Hospital, Salt Lake City, UT
Pancreatitis, Graft+2 More
18F-fluciclovine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

18F-Fluciclovine PET/CT in the Assessment of Pancreatic Transplants

See full description

Eligible Conditions

  • Pancreatitis, Graft
  • Pancreatic Transplant Post-Transplant Dysfunction Rejection

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether 18F-fluciclovine will improve 3 primary outcomes in patients with Pancreatitis, Graft. Measurement will happen over the course of These reviews will take place within 72 hours of the radiologic imaging taking place for each participant..

Hour 72
Measurement of Pancreatic Allograft Visibility after 18F-Fluciclovine Utilization
Hour 24
Measurement of Pancreatic Allograft Viability after 18F-Fluciclovine Utilization
Hour 72
Measurement of Pancreatic Allograft Uptake after 18F-Fluciclovine Utilization

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

18F fluciclovine Administration
1 of 1
Experimental Treatment

This trial requires 60 total participants across 1 different treatment group

This trial involves a single treatment. 18F-fluciclovine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

18F fluciclovine Administration
Drug
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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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).
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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). for reporting.

Who is running the study

Principal Investigator
S. W.
Prof. Sherry Wang, Assistant Professor
University of Utah

Closest Location

University of Utah Hospital - Salt Lake City, UT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
been done recently? Yes, pancreatic transplants are being done more frequently now. show original
She can agree to have an 18F-Fluciclovine PET/CT scan. show original
Only scans of non-diabetic patients will be included in the reviews of archived 18F-Fluciclovine PET/CT scans. show original
18 or over in age

Patient Q&A Section

What is the primary cause of pancreatitis?

"Primary pancreatitis can be caused by gallstones, hypertriglyceridemia and hyperglycemia, alcohol, NSAIDs, and [benign] gallstone disease. In secondary pancreatitis there are many causes and they can be caused by a multitude of different factors. Chronic pancreatitis occurs from several types of chronic pancreatitis. For further information visit www.paincreekonline.com:primary_pancreatitis/" - Anonymous Online Contributor

Unverified Answer

How many people get pancreatitis a year in the United States?

"Approximately 381,400 new diagnoses of acute pancreatitis will be recorded by 2030 in the United States. As an older population is diagnosed with diabetes, the number of new cases of chronic pancreatitis is expected to increase." - Anonymous Online Contributor

Unverified Answer

Can pancreatitis be cured?

"It is not possible to cure or prevent recurrent acute pancreatitis in the majority of patients. However, symptomatic treatment is effective in managing the debilitating symptoms associated with ongoing pancreatitis. At 5 years the majority of patients no longer require hospitalised care." - Anonymous Online Contributor

Unverified Answer

What is pancreatitis?

"Pancreatitis is a disease of the pancreas with a spectrum of signs and symptoms. Typically in older adults, pancreatitis is associated with a history of gallstones or alcoholism." - Anonymous Online Contributor

Unverified Answer

What are the signs of pancreatitis?

"The following signs point to a diagnosis of acute pancreatitis: vomiting blood, nausea or vomiting, lethargy, swollen fingers or toes, abdominal pain, bloody diarrhea, dehydration, low body temperature, and a positive Murphy's sign. The following other signs point to a diagnosis of chronic pancreatitis: unintentional weight loss, excessive thirst, inability to eat, and jaundice." - Anonymous Online Contributor

Unverified Answer

What are common treatments for pancreatitis?

"The most common treatment for acute pancreatitis is fluid replacement. In more serious cases, parenteral nutrition is often used to support the body after a severe bout of injury, and insulin is prescribed for pancreatic- insufficiency. These are not all of the usual treatments for pancreatitis.\n" - Anonymous Online Contributor

Unverified Answer

What causes pancreatitis?

"Pancreatitis is a complex disease (i.e., multiple factors are at least theoretically possible causes), with many possible etiologies. Genetic factors influencing several etiologies may be present. Atypical presentations and lack of definitive diagnostic criteria, such as diagnostic guidelines, may complicate the diagnostic analysis. At the present time, treatment is tailored after thorough workup of all known causes. The future may bring more precise etiologic links between pancreatitis and specific infectious, toxic, and systemic factors." - Anonymous Online Contributor

Unverified Answer

Is 18f-fluciclovine typically used in combination with any other treatments?

"Treatment with FDG-18F-FLU is currently used very rarely. However, due to the high rate of side effects, the clinical data demonstrating the superiority of FDG-18F-FLU in combination treatments do not justify the current low usage." - Anonymous Online Contributor

Unverified Answer

Has 18f-fluciclovine proven to be more effective than a placebo?

"It is suggested that MDR1 gene polymorphism is not an independent prognostic factor for the long-term outcome in APACHE II-staged children with inflammatory bowel disease. However, it seems to be significantly and independently associated with short-term response to (18)F-flucrifoxine therapy. An earlier initiation of therapy might also have improved the response." - Anonymous Online Contributor

Unverified Answer

What is 18f-fluciclovine?

"A study of the pharmacokinetics and pharmacodynamics of 18f-FLU in patients with pancreatitis showed a mean plasma concentration of the drug of 0.2 ng/mL. Therefore, the observed differences in the pharmacodynamics between studies could be explained by differences in treatment regimes and the time intervals between the administration of the drug. The fact that this study failed to show statistical correlation between 18f-FLU levels and patient outcome in pancreatitis suggests that this agent is not clinically useful in acute pancreatitis." - Anonymous Online Contributor

Unverified Answer

How serious can pancreatitis be?

"There are significant numbers of patients who are hospitalized for severe symptoms and complications who are never diagnosed with pancreatitis. Patients without conclusive signs, symptoms, or laboratory findings for pancreatitis could be treated medically with NSAIDs and oral analgesics." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for pancreatitis?

"Most clinical trials testing new therapies for chronic pancreatitis are restricted to patients who have mild disease or have endoscopic remission after initial therapy. Clinical trials that do offer treatment would be most appropriate for mild disease. Patients with severe or unremitting disease would be candidates for some clinical trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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