Visualizing Beta Cells After Islet Transplantation

Terminated

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Radiation: 68Ga-NODAGA-exendin PET/CT

• Registration Number: NCT03785236
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06-06
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Primary Completion: 2021-05-27
• Study Completion: 2021-05-27
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-29
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tx-group	68Ga-NODAGA-exendin PET/CT	T1D patients that received islet of Langerhans transplantation (Tx) at least 3 months earlier
Control group	68Ga-NODAGA-exendin PET/CT	T1D patients that await islet of Langerhans transplantation

Primary Outcome Measures

Name	Time	Method
Hepatic uptake of 68Ga-NODAGA-exendin-4	1 year	Hepatic uptake of 68Ga-NODAGA-exendin-4 obtained by quantitative analysis

Secondary Outcome Measures

Name	Time	Method
Islet graft function	1 year	Correlation of tracer uptake and islet graft function

Trial Locations

Locations (2)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Radboud university medical center; 🇳🇱 Nijmegen, Gelderland, Netherlands