Islet of Langerhans Graft Monitoring by Magnetic Resonance Imaging
NCT ID: NCT00453817
Last Updated: 2014-12-02
Study Results
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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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2005-06-30
2010-06-30
Brief Summary
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Detailed Description
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Islet isolation and transplantation Islets will be isolated and purified from pancreata harvested from multiorgan donors, according to the automated method described by Ricordi, with local modifications. After isolation, islets will be cultured overnight at 37°C in CMRL medium. After overnight culture, islets will be changed to fresh medium containing carbodextran-coated iron oxide nanoparticles (Resovist; Schering, Baar, Switzerland), at a target concentration of 5ul/ml, with a total dose not exceeding 0.08 ml/kg body weight, and further cultured for a total of 48-72 hours at 25°C until transplantation. Islet transplantation will be performed by intraportal infusion of the islet preparation, using a transhepatic percutaneous approach. Patients will receive infusions of at least 5,000 IEQ/kg. A second islet infusion will be administered to patients who have not reached insulin independence after the first transplant.
Graft monitoring and follow-up Patients will be followed for 1 year after last islet infusion. MRI will be performed prior to, 6 days, 6 weeks, 6 months and 1 year after islet infusion. A standard MRI protocol will be adapted. Since transplanted islets are already iron-labeled, no injection of contrast media will be done during MRI examination, and MRI sequences will not be repeated. After a scout image, axial views of the liver will be acquired with a fast gradient echo T2\* weighted sequence, a fast spin echo T2\* weighted sequence, ultrashort echo time T2\* weighted sequences, a spin echo T1 weighted sequence and in/out of phase fast gradient echo T1 weighted sequences. Iron-labeled islets will be visualized as a loss of signal on fast gradient echo T2\* weighted sequence, and the islet mass will be assessed in a semi-quantitative fashion using a visual scale. Finally, ultrashort echo time sequences will be used to generate a T2 map. The amount of iron contained inside the transplanted islets will be quantified based on the T2 map and the correction for the distribution of the iron particles inside the liver.
Monitoring results will be compared to islet function assessed by routine tests: exogenous insulin requirement, C-peptide, HbA1c, fructosamine, arginine stimulation test. Results will be analyzed retrospectively for the first 2 years. According to results of the analysis, the investigators may decide to intervene proactively (i.e. administer antirejection therapy) in the last year of the study, whenever results suggestive of a dysfunction are observed.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Study subjects
One-arm observational study
ferucarbotran (iron-based MRI contrast agent)
islets will be incubated with ferucarbotran prior to transplantation, for imaging after transplantation
Islet transplantation
intraportal percutaneous islet transplantation
Magnetic resonance imaging
Magnetic resonance imaging of the liver before and after islet transplantation (6 days, 6 weeks, 6 months, 1 year)
Interventions
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ferucarbotran (iron-based MRI contrast agent)
islets will be incubated with ferucarbotran prior to transplantation, for imaging after transplantation
Islet transplantation
intraportal percutaneous islet transplantation
Magnetic resonance imaging
Magnetic resonance imaging of the liver before and after islet transplantation (6 days, 6 weeks, 6 months, 1 year)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to undergo MRI (patients carrying osteosynthesis material, pacemakers or other metallic devices)
* Claustrophobia (tolerance to MRI)
* Hemosiderosis/hemochromatosis (interference with MRI signal)
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Thierry Berney
Professor of Surgery
Principal Investigators
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Thierry Berney, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Locations
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Geneva University Hospitals Department of Surgery
Geneva, , Switzerland
Countries
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Other Identifiers
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04-019
Identifier Type: -
Identifier Source: org_study_id