Imaging of Islet Transplantation With PET and MRT

NCT ID: NCT00417131

Last Updated: 2011-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2010-11-30

Brief Summary

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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

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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.

Conditions

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Islet Transplantation Diabetes Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Uppsala University Hospital

Principal Investigators

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Gunnar Tufveson, Professor

Role: PRINCIPAL_INVESTIGATOR

Dept of Transplantation, Uppsala University Hospital

Locations

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Karolinska University Hospital, Dept. of Transplantation surgery

Stockholm, , Sweden

Site Status

Uppsala University Hospital, Dept of Transplantation Surgery

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 19845588 (View on PubMed)

Other Identifiers

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Studieprotokoll 2006-05-12

Identifier Type: -

Identifier Source: org_study_id

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