Visualizing Beta Cells After Islet Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Visualizing Beta Cells After Intrahepatic Islet of Langerhans Transplantation

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Radiation: 68Ga-NODAGA-exendin PET/CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tx-group<br>T1D patients that received islet of Langerhans transplantation (Tx) at least 3 months earlier | Radiation: 68Ga-NODAGA-exendin PET/CT<br>* 68Ga-NODAGA-exendin PET/CT<br>|
| Control group<br>T1D patients that await islet of Langerhans transplantation | Radiation: 68Ga-NODAGA-exendin PET/CT<br>* 68Ga-NODAGA-exendin PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic uptake of 68Ga-NODAGA-exendin-4 | 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 | Correlation of tracer uptake and islet graft function | 1 year |