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

NCT04852523 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-09-03

No results posted yet for this study

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

Interventions

DRUG

18F-fluciclovine

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.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Yap, PhD · University of Utah

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2022-10-06
Completion
2022-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04852523 on ClinicalTrials.gov