Trial record 12 of 25 for:    Feridex

Islet of Langerhans Graft Monitoring by Magnetic Resonance Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00453817
Recruitment Status : Terminated (Feasibility issues)
First Posted : March 29, 2007
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):
Thierry Berney, University Hospital, Geneva

Brief Summary:
The primary objective of this pilot study is to assess the feasibility and safety of ex vivo islet labelling prior to intraportal transplantation in patients with type 1 diabetes with the purpose of islet graft imaging. The secondary objective is to determine the usefulness of this method for long-term islet graft monitoring.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: ferucarbotran (iron-based MRI contrast agent) Procedure: Islet transplantation Procedure: Magnetic resonance imaging Phase 1

Detailed Description:

The objectives will be addressed in a pilot study. We plan to enroll 15 patients over 3 years in islet transplantation alone (ITA), islet-after-kidney transplantation (IAK) or simultaneous islet-kidney transplantation (SIK) procedures. Patients will be followed-up for 1 year after transplantation.

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Suivi Par résonance magnétique après Transplantation d'îlots de Langerhans
Study Start Date : June 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Study subjects
One-arm observational study
Drug: ferucarbotran (iron-based MRI contrast agent)
islets will be incubated with ferucarbotran prior to transplantation, for imaging after transplantation

Procedure: Islet transplantation
intraportal percutaneous islet transplantation

Procedure: Magnetic resonance imaging
Magnetic resonance imaging of the liver before and after islet transplantation (6 days, 6 weeks, 6 months, 1 year)

Primary Outcome Measures :
  1. Semi-quantitative assessment of intrahepatic MRI signal on T2*-weighted sequences, at 6 days, 6 weeks, 6 months and 1 year after transplantation [ Time Frame: 2005-2009 ]

Secondary Outcome Measures :
  1. Islet graft function assessed by exogenous insulin requirements, HbA1c, mean amplitude of glucose excursions (MAGE) and fasting C-peptide. [ Time Frame: 2005-2009 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients on the waiting list for an islet of Langerhans transplantation procedure

Exclusion Criteria:

  • Allergy to ferucarbotran
  • Inability to undergo MRI (patients carrying osteosynthesis material, pacemakers or other metallic devices)
  • Claustrophobia (tolerance to MRI)
  • Hemosiderosis/hemochromatosis (interference with MRI signal)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00453817

Geneva University Hospitals Department of Surgery
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Principal Investigator: Thierry Berney, MD, MSc University Hospital, Geneva

Responsible Party: Thierry Berney, Professor of Surgery, University Hospital, Geneva Identifier: NCT00453817     History of Changes
Other Study ID Numbers: 04-019
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Thierry Berney, University Hospital, Geneva:
islet transplantation
graft monitoring
magnetic resonance imaging

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases