MRI Imaging of Labeled Human Islets Transplanted Into the Liver

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-15

Study Completion Date

2012-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Labeled islets

Type 1 diabetic recipients after islet transplantation with islets labeled by iron contrast agent

Transplantation of labeled islets

Intervention Type OTHER

Interventions

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Transplantation of labeled islets

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No