Viewing Study NCT00417131



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Study NCT ID: NCT00417131
Status: COMPLETED
Last Update Posted: 2011-08-04
First Post: 2006-12-28

Brief Title: Imaging of Islet Transplantation With PET and MRT
Sponsor: Uppsala University Hospital
Organization: Uppsala University Hospital

Study Overview

Official Title: Imaging of Islet Transplantation With PET and MRT
Status: COMPLETED
Status Verified Date: 2008-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None