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

Primary Purpose

Pancreatitis, Graft, Pancreatic Transplant Post-Transplant Dysfunction Rejection

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-fluciclovine
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatitis, Graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

- Patient with known prostate cancer

Sites / Locations

  • University of Utah Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F fluciclovine Administration

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2021
Last Updated
October 11, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT04852523
Brief Title
18F-Fluciclovine PET/CT in the Assessment of Pancreatic Transplants
Official Title
Assessing the Value of 18F-Fluciclovine PET/CT in the Assessment of Pancreatic Transplants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
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. The 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. Pancreas transplants are usually assessed via ultrasound as a first-line modality. However, visualization is largely obscured due to the intraperitoneal location of the transplant. There is often overlying gas and due to the depth of the transplant, there is poor visualization with ultrasound. Additionally, the transplant lacks a capsule which results in its being ill-defined and difficult to distinguish from adjacent structures. Computed tomography can also be used to assess pancreas transplants, however, most transplant patients often have concurrent renal transplants which limits the use of intravenous iodinated contrast. On non-contrast CT, it can be difficult to assess and distinguish the pancreas transplant from the adjacent bowel. Magnetic Resonance Imaging (MRI) can be useful and has better soft-tissue contrast compared to CT. However, it has a similar issue with regards to limited intravenous gadolinium contrast administration due to concurrent renal transplant in this group of patients. In all three modalities, there is no functional assessment of the allograft and whether there is still appropriate pancreatic function. This is the reason for our proposed study, given that 18F-Fluciclovine is readily taken up by the pancreas and it would help radiologists readily identify where the allograft is located, whether it is viable, and whether there is a normal function of the allograft. It should be noted that leucine serves both as a fuel, as well as in a regulatory capacity for pancreatic beta-cell function. However, uptake of 18F-Fluciclovine in the pancreas is not likely to be specific for beta-cell function since acinar cell function requires L-amino acids. However, overall pancreatic viability is relevant to both acinar cell and beta-cell function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Graft, Pancreatic Transplant Post-Transplant Dysfunction Rejection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F fluciclovine Administration
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
18F-fluciclovine
Other Intervention Name(s)
Axumin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of Pancreatic Allograft Viability after 18F-Fluciclovine Utilization
Description
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.
Time Frame
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).
Title
Measurement of Pancreatic Allograft Visibility after 18F-Fluciclovine Utilization
Description
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.
Time Frame
These reviews will take place within 72 hours of the radiologic imaging taking place for each participant.
Title
Measurement of Pancreatic Allograft Uptake after 18F-Fluciclovine Utilization
Description
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.
Time Frame
This outcome will be measured after the radiologic images have been processed and archived (within 72 hours of intervention).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 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. Exclusion Criteria: - Patient with known prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Yap, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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