Visualizing Beta Cells After Islet Transplantation (GLP1-transpl)

Radboud University Medical Center

Status: Terminated

Conditions: Type 1 Diabetes Mellitus

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

Study type: Observational

Funder types: Other

Identifiers

NCT03785236

NL52630.091.15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

13 participants in 2 patient groups

Tx-group

Description:

T1D patients that received islet of Langerhans transplantation (Tx) at least 3 months earlier

Treatment:

Radiation: 68Ga-NODAGA-exendin PET/CT

Control group

Description:

T1D patients that await islet of Langerhans transplantation

Treatment:

Radiation: 68Ga-NODAGA-exendin PET/CT