NCT00417131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

August 4, 2011

Status Verified

July 1, 2008

Enrollment Period

4.1 years

First QC Date

December 28, 2006

Last Update Submit

August 3, 2011

Conditions

Islet TransplantationDiabetes Type 1

Keywords

Islet transplantation,coagulation,graft destruction,islet imaging

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to islet transplantation in the Nordic countries (Scandinavia)

You may qualify if:

  • Patients suitable for clinical islet transplantation.
  • Patient on waiting list for islet transplantation within the Nordic Network for Clinical Islet Transplantation
  • Written Informed Concent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska University Hospital, Dept. of Transplantation surgery

Stockholm, S-141 86, Sweden

Location

Uppsala University Hospital, Dept of Transplantation Surgery

Uppsala, S-751 85, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 19845588DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Thrombosis

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Gunnar Tufveson, Professor

    Dept of Transplantation, Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2006

First Posted

December 29, 2006

Study Start

October 1, 2006

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 4, 2011

Record last verified: 2008-07

Locations

SE(2)