- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01050166
MRI Imaging of Labeled Human Islets Transplanted Into the Liver
April 22, 2021 updated by: Frantisek Saudek
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
8
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Prague, Czechia, 14000
- Diabetes Center, Institute for Clinical and Experimental Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cohort will be selected from residents of Czech republic
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Labeled islets
Type 1 diabetic recipients after islet transplantation with islets labeled by iron contrast agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evidence of safety and efficacy of MRI imaging of transplanted human labeled islets
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frantisek Saudek, MD, DrSc, Institute for Clinical and Experimental Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 15, 2008
Primary Completion (Actual)
December 15, 2012
Study Completion (Actual)
December 31, 2012
Study Registration Dates
First Submitted
January 14, 2010
First Submitted That Met QC Criteria
January 14, 2010
First Posted (Estimate)
January 15, 2010
Study Record Updates
Last Update Posted (Actual)
April 26, 2021
Last Update Submitted That Met QC Criteria
April 22, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD MRI IKEM 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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