Pancreatitis, GraftEarly Phase 1NCT04852523
18F-Fluciclovine PET/CT in the Assessment of Pancreatic Transplants
A Early Phase 1 study testing 18F-fluciclovine in people with Pancreatitis, Graft and Pancreatic Transplant Post-Transplant Dysfunction Rejection, run by University of Utah at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatitis, Graft, Pancreatic Transplant Post-Transplant Dysfunction Rejection
- What is being tested?
- 18F-fluciclovine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to 6 Oct 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient with known prostate cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospital
Salt Lake City, Utah, 84132
About this study
Official title: Assessing the Value of 18F-Fluciclovine PET/CT in the Assessment of Pancreatic Transplants
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
Read the 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.
- Being tested
- 18F-fluciclovine
- Medical subject headings
- Pancreatitis, Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluciclovineDrug
Also called Axumin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 18F-fluciclovine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: This outcome will be measured after the radiologic images have been processed and archived (within 72 hours of intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start16 Sep 2021
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, GraftStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Yap, PhD, University of Utah
- Investigators
- Jeffrey Yap, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852523
- Sponsor's protocol ID
- 136948
- Status last verified
- Aug 2024
- First submitted
- 9 Apr 2021
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Value of 18F-Fluciclovine PET/CT in the Assessment of Pancreatic Transplants
- ClinicalTrials.gov ID
- NCT04852523
- Acronym / sponsor ID
- 136948
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F fluciclovine Administration | Experimental | Drug: 18F-fluciclovine* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient with known prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-fluciclovineAlso: Axumin18F-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. | Drug | 18F fluciclovine Administration |
Primary outcome
Measurement of Pancreatic Allograft Viability after 18F-Fluciclovine Utilization
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).
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
Time frame: These reviews will take place within 72 hours of the radiologic imaging taking place for each participant.
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
Time frame: This outcome will be measured after the radiologic images have been processed and archived (within 72 hours of intervention).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreatitis, Graft
RecruitingObservational study
Analysis of Graft Function Following Autologous Islet Transplantation
Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Yap, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-fluciclovine in people with Pancreatitis, Graft and Pancreatic Transplant Post-Transplant Dysfunction Rejection, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Pancreatic Allograft Viability after 18F-Fluciclovine Utilization (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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.