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Islet of Langerhans Graft Monitoring by Magnetic Resonance Imaging

NCT00453817 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-12-02

No results posted yet for this study

Summary

The primary objective of this pilot study is to assess the feasibility and safety of ex vivo islet labelling prior to intraportal transplantation in patients with type 1 diabetes with the purpose of islet graft imaging. The secondary objective is to determine the usefulness of this method for long-term islet graft monitoring.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

ferucarbotran (iron-based MRI contrast agent)

islets will be incubated with ferucarbotran prior to transplantation, for imaging after transplantation

PROCEDURE

Islet transplantation

intraportal percutaneous islet transplantation

PROCEDURE

Magnetic resonance imaging

Magnetic resonance imaging of the liver before and after islet transplantation (6 days, 6 weeks, 6 months, 1 year)

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Thierry Berney, MD, MSc · University Hospital, Geneva

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00453817 on ClinicalTrials.gov