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NCT03785236 Clinical Trial

Visualizing Beta Cells After Islet Transplantation

Type 1 Diabetes Mellitus Clinical Trial

— GLP1-transpl  

Official title:
Visualizing Beta Cells After Intrahepatic Islet of Langerhans Transplantation

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03785236
Other study ID # NL52630.091.15
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 6, 2016
Est. completion date May 27, 2021

Study information
Verified date January 2022
Source Radboud University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 13
Est. completion date May 27, 2021
Est. primary completion date May 27, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Radiation:
• 68Ga-NODAGA-exendin PET/CT
68Ga-NODAGA-exendin PET/CT

Locations
Country Name City State
Netherlands Radboud university medical center Nijmegen Gelderland
Sweden Uppsala University Hospital Uppsala

Sponsors (1)
Lead Sponsor Collaborator
Radboud University Medical Center

Countries where clinical trial is conducted

Netherlands,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hepatic uptake of 68Ga-NODAGA-exendin-4 Hepatic uptake of 68Ga-NODAGA-exendin-4 obtained by quantitative analysis 1 year
Secondary Islet graft function Correlation of tracer uptake and islet graft function 1 year
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