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Imaging of Islet Transplantation With PET and MRT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00417131
First Posted: December 29, 2006
Last Update Posted: August 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Uppsala University Hospital
  Purpose
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.

Condition
Islet Transplantation Diabetes Type 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging of Islet Transplantation With PET and MRT

Resource links provided by NLM:


Further study details as provided by Uppsala University Hospital:

Enrollment: 8
Study Start Date: October 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to islet transplantation in the Nordic countries (Scandinavia)
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417131


Locations
Sweden
Karolinska University Hospital, Dept. of Transplantation surgery
Stockholm, Sweden, S-141 86
Uppsala University Hospital, Dept of Transplantation Surgery
Uppsala, Sweden, S-751 85
Sponsors and Collaborators
Uppsala University Hospital
Investigators
Principal Investigator: Gunnar Tufveson, Professor Dept of Transplantation, Uppsala University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gunnar Tufveson, MD, Professor, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT00417131     History of Changes
Other Study ID Numbers: Studieprotokoll 2006-05-12
First Submitted: December 28, 2006
First Posted: December 29, 2006
Last Update Posted: August 4, 2011
Last Verified: July 2008

Keywords provided by Uppsala University Hospital:
Islet transplantation,
coagulation,
graft destruction,
islet imaging

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases