Clinical trial NCT00417131: Imaging of Islet Transplantation With PET and MRT
Official title: Imaging of Islet Transplantation With PET and MRT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Islet Transplantation
Diabetes Type 1
Keywords: Islet transplantation,
coagulation,
graft destruction,
islet imaging
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2006-12-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to islet transplantation in the Nordic countries (Scandinavia)

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Dept. of Transplantation surgery
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Dept of Transplantation Surgery
Study officials:
affiliation: Dept of Transplantation, Uppsala University Hospital
name: Gunnar Tufveson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eriksson O, Eich T, Sundin A, Tibell A, Tufveson G, Andersson H, Felldin M, Foss A, Kyllonen L, Langstrom B, Nilsson B, Korsgren O, Lundgren T. Positron emission tomography in clinical islet transplantation. Am J Transplant. 2009 Dec;9(12):2816-24. doi: 10.1111/j.1600-6143.2009.02844.x. Epub 2009 Oct 21.