Islet of Langerhans Graft Monitoring by Magnetic Resonance Imaging

NCT00453817 | Terminated Phase 1

• 1 other identifier: 04-019
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

islet transplantation; imaging; graft monitoring; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Semi-quantitative assessment of intrahepatic MRI signal on T2*-weighted sequences, at 6 days, 6 weeks, 6 months and 1 year after transplantation

  2005-2009

Secondary Outcomes (1)

• Islet graft function assessed by exogenous insulin requirements, HbA1c, mean amplitude of glucose excursions (MAGE) and fasting C-peptide.

  2005-2009

Study Arms (1)

Study subjects

EXPERIMENTAL

One-arm observational study

Drug: ferucarbotran (iron-based MRI contrast agent); Procedure: Islet transplantation; Procedure: Magnetic resonance imaging

Interventions

ferucarbotran (iron-based MRI contrast agent) DRUG

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

Study subjects

Islet transplantation PROCEDURE

intraportal percutaneous islet transplantation

Study subjects

Magnetic resonance imaging PROCEDURE

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

Study subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients on the waiting list for an islet of Langerhans transplantation procedure

You may not qualify if:

• Allergy to ferucarbotran
• Inability to undergo MRI (patients carrying osteosynthesis material, pacemakers or other metallic devices)
• Claustrophobia (tolerance to MRI)
• Hemosiderosis/hemochromatosis (interference with MRI signal)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals Department of Surgery

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

ferumoxides; Islets of Langerhans Transplantation; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Endocrine Surgical Procedures; Surgical Procedures, Operative; Transplantation; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Thierry Berney, MD, MSc

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: March 29, 2007
• Study Start: June 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

CH (1)