Visualizing Beta Cells After Islet Transplantation

NCT ID: NCT03785236

Last Updated: 2022-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-06

Study Completion Date

2021-05-27

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.

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Tx-group

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

68Ga-NODAGA-exendin PET/CT

Intervention Type RADIATION

68Ga-NODAGA-exendin PET/CT

Control group

T1D patients that await islet of Langerhans transplantation

68Ga-NODAGA-exendin PET/CT

Intervention Type RADIATION

68Ga-NODAGA-exendin PET/CT

Interventions

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68Ga-NODAGA-exendin PET/CT

68Ga-NODAGA-exendin PET/CT

Intervention Type RADIATION

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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radboud university medical center

Nijmegen, Gelderland, Netherlands

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Netherlands Sweden

Other Identifiers

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NL52630.091.15

Identifier Type: -

Identifier Source: org_study_id

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