Clinical trial

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

Name

136948

Description

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

Trial arms

Trial start

2021-09-16

Estimated PCD

2022-10-06

Trial end

2022-10-06

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

18F fluciclovine Administration

Other names:

Axumin

Size

Primary endpoint

Measurement of Pancreatic Allograft Viability after 18F-Fluciclovine Utilization

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

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

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

Updated at

2024-01-17

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication

Pancreatic Transplant Post-Transplant Dysfunction Rejection