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Completed

NCT Number: NCT01050166

MRI Imaging of Labeled Human Islets Transplanted Into the Liver

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diabetes Center, Institute for Clinical and Experimental Medicine

Prague, 14000, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transplantation of labeled islets

Other

Primary outcomes

  1. Evidence of safety and efficacy of MRI imaging of transplanted human labeled islets

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Frantisek Saudek

Other Gov

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 15, 2010
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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