Imaging of Islet Transplantation With PET and MRT

August 3, 2011 updated by: Uppsala University Hospital
Islets of Langerhans intended for clinical transplantation are labelled with a radioactive tracer. The tracer is retained in viable cells of the transplant. At infusion (transplantation) of the islets into the portal vein the tracer can be followed for two hours with positron emission tomography (PET). Imaging and calculations can give estimates of the proportion of surveying islets and the rate of early destruction. Also the distribution of the islets into the liver can be viewed.

Study Overview

Status

Completed

Conditions

Detailed Description

Background:

It is suspected that the current need for repeated islets transplantation to treat diabetes type I is dependent on an early destruction of the islets when infused into the portal vein.

Aim:

To trace the fate of the islet at and after infusion into the portal vein.

Method:

Islets are labelled in vitro with a radioactive tracer that can be measured with positron emission tomography. 10-20 percent of the graft is labelled. Just prior to start of infusion labelled islets are mixed with unlabelled islets (80-90 percent of the graft). The tracer used is FDG and stands for 2-[18F]-2-deoxy-D-glucose. At infusion the patient is placed in the combined computer tomography and PET camera to follow the infusion. The imaging is almost continuous for 2 h at and after infusion.

Expected results:

Calculations of proportion of surviving islets and rate of destruction. Localisation and distribution of islets in the liver of the recipient.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, S-141 86
        • Karolinska University Hospital, Dept. of Transplantation surgery
      • Uppsala, Sweden, S-751 85
        • Uppsala University Hospital, Dept of Transplantation Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred to islet transplantation in the Nordic countries (Scandinavia)

Description

Inclusion Criteria:

  • Patients suitable for clinical islet transplantation.
  • Patient on waiting list for islet transplantation within the Nordic Network for Clinical Islet Transplantation
  • Written Informed Concent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Investigators

  • Principal Investigator: Gunnar Tufveson, Professor, Dept of Transplantation, Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 28, 2006

First Submitted That Met QC Criteria

December 28, 2006

First Posted (Estimate)

December 29, 2006

Study Record Updates

Last Update Posted (Estimate)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Studieprotokoll 2006-05-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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