MRI Imaging of Labeled Human Islets Transplanted Into the Liver

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01050166
• Other study ID #: CD MRI IKEM 1
• Status: Completed
• Start date: August 15, 2008
• Est. completion date: December 31, 2012

Study information

• Verified date: April 2021
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 31, 2012
• Est. primary completion date: December 15, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• Transplantation of labeled islets

Locations

Country	Name	City	State
Czechia	Diabetes Center, Institute for Clinical and Experimental Medicine	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Frantisek Saudek

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Saudek F, Jirák D, Girman P, Herynek V, Dezortová M, Kríz J, Peregrin J, Berková Z, Zacharovová K, Hájek M. Magnetic resonance imaging of pancreatic islets transplanted into the liver in humans. Transplantation. 2010 Dec 27;90(12):1602-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of safety and efficacy of MRI imaging of transplanted human labeled islets		1 year