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MRI Imaging of Labeled Human Islets Transplanted Into the Liver

This study is currently recruiting participants.
Verified January 2010 by Institute for Clinical and Experimental Medicine
Sponsor:
Information provided by:
Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT01050166
First received: January 14, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention Phase
Type 1 Diabetes Mellitus
 Other: Transplantation of labeled islets
 Phase 1

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute for Clinical and Experimental Medicine:

Primary Outcome Measures:
  • Evidence of safety and efficacy of MRI imaging of transplanted human labeled islets [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: August 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Labeled islets
Type 1 diabetic recipients after islet transplantation with islets labeled by iron contrast agent
 Other: Transplantation of labeled islets
not applicable

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 14, 2010
Last Updated: January 14, 2010
Health Authority: Czech Republic: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on May 16, 2013