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MRI Imaging of Labeled Human Islets Transplanted Into the Liver

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ClinicalTrials.gov Identifier: NCT01050166
Recruitment Status : Unknown
Verified January 2010 by Institute for Clinical and Experimental Medicine.
Recruitment status was:  Recruiting
First Posted : January 15, 2010
Last Update Posted : January 15, 2010
Sponsor:
Information provided by:
Institute for Clinical and Experimental Medicine

Brief Summary:
The purpose of the study is to determine whether human islets labeled by iron contrast agents could be imaged using magnetic resonance after transplantation into the liver of Type 1 diabetic recipients.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Other: Transplantation of labeled islets

Detailed Description:
Islet transplantation represents approved therapeutic approach in selected Type 1 diabetic recipients with syndrome of hypoglycaemia unawareness. Existing imaging methods are not sufficient to provide adequate information about amount and fate of islets transplanted into the liver. Labeling of islets with superparamagnetic contrast agent ferucarbotran significantly shortens T2 relaxing time and therefore increase the contrast between islets and liver tissue in magnetic resonance imaging. In consequence, islets transplanted into liver could be easily detectable like hypotensive areas dispersed throughout the liver. MRI examination will be done on 1, 2, 4 weeks and 3, 6 and 12 months.

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 1 Study to Test Safety and Efficacy of Magnetic Resonance Imaging of Human Labeled Islets Transplanted Into the Liver in Type 1 Diabetic Recipients
Study Start Date : August 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Labeled islets
Type 1 diabetic recipients after islet transplantation with islets labeled by iron contrast agent
Other: Transplantation of labeled islets



Primary Outcome Measures :
  1. Evidence of safety and efficacy of MRI imaging of transplanted human labeled islets [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohort will be selected from residents of Czech republic
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus
  • normal renal parameters
  • hypoglycaemia unawareness or rapid progression of diabetic retinopathy or neuropathy

Exclusion Criteria:

  • acute and chronic liver disease
  • malignancy
  • acute infection
  • serious cardiovascular disease
  • coagulopathy
  • portal hypertension
  • presence of metal protesis, cardio-stimulators, or other metal material in the body

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 ClinicalTrials.gov identifier (NCT number): NCT01050166


Contacts
Contact: Frantisek Saudek, MD, DrSc +420261364107 frsa@ikem.cz

Locations
Czech Republic
Diabetes Center, Institute for Clinical and Experimental Medicine Recruiting
Prague, Czech Republic, 14000
Contact: Saudek    +420261364107    frsa@ikem.cz   
Principal Investigator: Frantisek Saudek, MD, DrSc         
Sub-Investigator: Milan Hajek         
Sub-Investigator: Peter Girman, MD, PhD         
Sub-Investigator: Monika Dezortova         
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Investigators
Principal Investigator: Frantisek Saudek, MD, DrSc Institute for Clinical and Experimental Medicine

Responsible Party: Doc. MUDr.Jan Maly CSc, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT01050166     History of Changes
Other Study ID Numbers: CD MRI IKEM 1
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010

Keywords provided by Institute for Clinical and Experimental Medicine:
islet transplantation
magnetic resonance
Type 1 DM

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