MRI Imaging of Labeled Human Islets Transplanted Into the Liver

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: Transplantation of labeled islets

• Registration Number: NCT01050166
• Lead Sponsor: Frantisek Saudek

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.

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 Timeline

• Study Start: 2008-08-15
• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-15
• Primary Completion: 2012-12-15
• Study Completion: 2012-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Labeled islets	Transplantation of labeled islets	Type 1 diabetic recipients after islet transplantation with islets labeled by iron contrast agent

Primary Outcome Measures

Name	Time	Method
Evidence of safety and efficacy of MRI imaging of transplanted human labeled islets	1 year

Trial Locations

Locations (1)

Diabetes Center, Institute for Clinical and Experimental Medicine; 🇨🇿 Prague, Czechia