Imaging of Islet Transplantation With PET and MRT

This study has been completed.
Sponsor:
Information provided by:
Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT00417131
First received: December 28, 2006
Last updated: August 3, 2011
Last verified: July 2008
  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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Uppsala University Hospital

Additional 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
Study First Received: December 28, 2006
Last Updated: August 3, 2011
Health Authority: Sweden: Swedish National Council on Medical Ethics

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

ClinicalTrials.gov processed this record on August 28, 2014