- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00417131
Imaging of Islet Transplantation With PET and MRT
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Stockholm, Sweden, S-141 86
- Karolinska University Hospital, Dept. of Transplantation surgery
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Uppsala, Sweden, S-751 85
- Uppsala University Hospital, Dept of Transplantation Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gunnar Tufveson, Professor, Dept of Transplantation, Uppsala University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Studieprotokoll 2006-05-12
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