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

NCT04852523 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 136948
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis 1: 18F-Fluciclovine PET/CT can correctly and easily identify the pancreatic allograft and determine its viability Aim 1: Assess whether 18F-Fluciclovine can identify the pancreatic allograft accurately and assess its viability and visibility Hypothesis 2: 18F-Fluciclovine PET/CT uptake in the pancreas (SUV) is related to total pancreatic function and therefore can indicate whether the pancreatic allograft is at risk of rejection Aim 2: Assess whether 18F-Fluciclovine uptake in the pancreas can be a surrogate for pancreatic function

Conditions

Pancreatitis, Graft; Pancreatic Transplant Post-Transplant Dysfunction Rejection

Outcome Measures

Primary Outcomes (3)

• Measurement of Pancreatic Allograft Viability after 18F-Fluciclovine Utilization

  Regions of Interest (ROI) will be placed on the pancreas to determine the standardized uptake value (SUV) which requires the correlation of the patient's standard of care laboratory results. A higher SUV result would indicate stronger viability for the allograft.

  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).

• Measurement of Pancreatic Allograft Visibility after 18F-Fluciclovine Utilization

  Pancreatic allograft visibility after the use of 18F-Fluciclovine will be measured by 3 separate nuclear medicine/ radiology readers. Each reviewer will grade the images on a scale from 1 to 5, 5 being the most visible when compared to the non-contrast CT images.

  These reviews will take place within 72 hours of the radiologic imaging taking place for each participant.

• Measurement of Pancreatic Allograft Uptake after 18F-Fluciclovine Utilization

  Regions of Interest (ROI) will be placed on the pancreas to determine the standardized uptake value (SUV). A higher SUV result will indicate a higher likelihood that allograft rejection is not/will not take place.

  This outcome will be measured after the radiologic images have been processed and archived (within 72 hours of intervention).

Study Arms (1)

18F fluciclovine Administration

EXPERIMENTAL

* 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.

Drug: 18F-fluciclovine

Interventions

18F-fluciclovine DRUG

18F-Fluciclovine is a synthetic L-leucine amino acid used clinically for PET imaging in patients with biochemical recurrence of prostate cancer following definitive therapy. The pancreas accumulates striking amounts of Axumin, where it is considered a normal finding. Pancreatic beta-cell function may be slow to recover following pancreatic transplantation and may vary as a function of perioperative steroid administration, acute rejection, inadequate islet cell transplantation, allograft pancreatitis or compromised blood supply. Viability of the allograft is a common clinical concern and is difficult to assess based on insulin, C-peptide, and blood sugar levels. Rapid identification of compromised allograft viability is critical in the management of these patients.

Also known as: Axumin

18F fluciclovine Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or over in age
• Have any type of pancreatic transplant
• Able to consent for 18F-Fluciclovine PET/CT scan
• For archived 18F-Fluciclovine PET/CT scan reviews, only scans of non-diabetic patients will be included.

You may not qualify if:

• \- Patient with known prostate cancer

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Pancreatitis, Graft

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Jeffrey Yap, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 21, 2021
• Study Start: September 16, 2021
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: September 3, 2024

Record last verified: 2024-08

Locations

US (1)