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MRI Imaging of Labeled Human Islets Transplanted Into the Liver

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Institute for Clinical and Experimental Medicine.
Recruitment status was:  Recruiting
Information provided by:
Institute for Clinical and Experimental Medicine Identifier:
First received: January 14, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
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:

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

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01050166

Czech Republic
Diabetes Center, Institute for Clinical and Experimental Medicine
Prague, Czech Republic, 14000
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Principal Investigator: Frantisek Saudek, MD, DrSc Institute for Clinical and Experimental Medicine
  More Information

Responsible Party: Doc. MUDr.Jan Maly CSc, Institute for Clinical and Experimental Medicine 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 processed this record on January 17, 2017