- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03785236
Visualizing Beta Cells After Islet Transplantation (GLP1-transpl)
January 29, 2022 updated by: Radboud University Medical Center
Visualizing Beta Cells After Intrahepatic Islet of Langerhans Transplantation
In patients with type 1 diabetes (T1D) that have undergone islet of Langerhans transplantation or are on the waiting list for transplantation, Ga-68-exendin PET imaging is performed to study the visualization of transplanted islet grafts in patients.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Detecting damage to islets with a reliable imaging technique could be important for improving islet survival after transplantation.
This could lead to better patient outcomes which would be of great interest for the treatment of type 1 diabetes.
In order to assess the possibility of visualizing transplanted islet grafts with Ga-68-NODAGA-exendin-4 PET, a proof-of -concept study is performed in 10 patients with type 1 diabetes who have undergone intrahepatic islet transplantation with biochemically proven functional islet grafts and 5 patients with type 1 diabetes who are on the waiting list for islet transplantation.
The investigators propose to determine the uptake of the radiolabeled tracer and compare it to functionality of the islet grafts.
These highly relevant data will provide us with more information on the suitability of GLP-1 receptor imaging for monitoring of transplanted islet mass.
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gelderland
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Nijmegen, Gelderland, Netherlands, 6525 GA
- Radboud University Medical Center
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-
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Uppsala, Sweden, SE-751 85
- Uppsala University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The population consists of 10 individuals with type 1 diabetes patients who have undergone intrahepatic islet transplantation at least 3 months earlier at.
Furthermore, 5 T1D patients without an islet transplant will be included as a control for uptake of the radiotracer in the liver.
All participating individuals need to be 18 years or older.
In total, 15 participants will be included.
Description
Inclusion Criteria
Tx-group:
- >18 years old
- T1D patient undergone islet transplantation
- Clinically proven functional islet graft
- Signed informed consent
Control group:
- >18 years old
- T1D patients who are on the waiting list for islet transplantation
- Signed informed consent
Exclusion Criteria:
- Treatment with synthetic exendin or Dipeptidyl-Peptidase IV inhibitors within the last 3 months
- Breast feeding
- Pregnancy or the wish to become pregnant within 6 months
- Kidney disease
- Liver disease
- Age <18 years
- No signed informed consent
Exclusion criteria for MR:
- fragments, clips or devices in brain, eyes, spinal canal
- Implantable defibrillator or pacemaker (wires)
- Mandibular magnetic implants
- Neurostimulator, bladder stimulator, non-removable insulin pump
- Metal tissue-expander in chest
- Cochlear implant
- Ossicular replacement prosthesis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Tx-group
T1D patients that received islet of Langerhans transplantation (Tx) at least 3 months earlier
|
68Ga-NODAGA-exendin PET/CT
|
Control group
T1D patients that await islet of Langerhans transplantation
|
68Ga-NODAGA-exendin PET/CT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hepatic uptake of 68Ga-NODAGA-exendin-4
Time Frame: 1 year
|
Hepatic uptake of 68Ga-NODAGA-exendin-4 obtained by quantitative analysis
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Islet graft function
Time Frame: 1 year
|
Correlation of tracer uptake and islet graft function
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2016
Primary Completion (Actual)
May 27, 2021
Study Completion (Actual)
May 27, 2021
Study Registration Dates
First Submitted
December 20, 2018
First Submitted That Met QC Criteria
December 20, 2018
First Posted (Actual)
December 24, 2018
Study Record Updates
Last Update Posted (Actual)
February 14, 2022
Last Update Submitted That Met QC Criteria
January 29, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL52630.091.15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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