Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453817
Status:
TERMINATED
Last Update Posted:
2014-12-02
First Post:
2006-10-04
Brief Title:
Islet of Langerhans Graft Monitoring by Magnetic Resonance Imaging
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Suivi Par résonance magnétique après Transplantation dîlots de Langerhans
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Feasibility issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The objectives will be addressed in a pilot study We plan to enroll 15 patients over 3 years in islet transplantation alone ITA islet-after-kidney transplantation IAK or simultaneous islet-kidney transplantation SIK procedures Patients will be followed-up for 1 year after transplantation
Islet isolation and transplantation Islets will be isolated and purified from pancreata harvested from multiorgan donors according to the automated method described by Ricordi with local modifications After isolation islets will be cultured overnight at 37C in CMRL medium After overnight culture islets will be changed to fresh medium containing carbodextran-coated iron oxide nanoparticles Resovist Schering Baar Switzerland at a target concentration of 5ulml with a total dose not exceeding 008 mlkg body weight and further cultured for a total of 48-72 hours at 25C until transplantation Islet transplantation will be performed by intraportal infusion of the islet preparation using a transhepatic percutaneous approach Patients will receive infusions of at least 5000 IEQkg A second islet infusion will be administered to patients who have not reached insulin independence after the first transplant
Graft monitoring and follow-up Patients will be followed for 1 year after last islet infusion MRI will be performed prior to 6 days 6 weeks 6 months and 1 year after islet infusion A standard MRI protocol will be adapted Since transplanted islets are already iron-labeled no injection of contrast media will be done during MRI examination and MRI sequences will not be repeated After a scout image axial views of the liver will be acquired with a fast gradient echo T2 weighted sequence a fast spin echo T2 weighted sequence ultrashort echo time T2 weighted sequences a spin echo T1 weighted sequence and inout of phase fast gradient echo T1 weighted sequences Iron-labeled islets will be visualized as a loss of signal on fast gradient echo T2 weighted sequence and the islet mass will be assessed in a semi-quantitative fashion using a visual scale Finally ultrashort echo time sequences will be used to generate a T2 map The amount of iron contained inside the transplanted islets will be quantified based on the T2 map and the correction for the distribution of the iron particles inside the liver
Monitoring results will be compared to islet function assessed by routine tests exogenous insulin requirement C-peptide HbA1c fructosamine arginine stimulation test Results will be analyzed retrospectively for the first 2 years According to results of the analysis the investigators may decide to intervene proactively ie administer antirejection therapy in the last year of the study whenever results suggestive of a dysfunction are observed
Islet isolation and transplantation Islets will be isolated and purified from pancreata harvested from multiorgan donors according to the automated method described by Ricordi with local modifications After isolation islets will be cultured overnight at 37C in CMRL medium After overnight culture islets will be changed to fresh medium containing carbodextran-coated iron oxide nanoparticles Resovist Schering Baar Switzerland at a target concentration of 5ulml with a total dose not exceeding 008 mlkg body weight and further cultured for a total of 48-72 hours at 25C until transplantation Islet transplantation will be performed by intraportal infusion of the islet preparation using a transhepatic percutaneous approach Patients will receive infusions of at least 5000 IEQkg A second islet infusion will be administered to patients who have not reached insulin independence after the first transplant
Graft monitoring and follow-up Patients will be followed for 1 year after last islet infusion MRI will be performed prior to 6 days 6 weeks 6 months and 1 year after islet infusion A standard MRI protocol will be adapted Since transplanted islets are already iron-labeled no injection of contrast media will be done during MRI examination and MRI sequences will not be repeated After a scout image axial views of the liver will be acquired with a fast gradient echo T2 weighted sequence a fast spin echo T2 weighted sequence ultrashort echo time T2 weighted sequences a spin echo T1 weighted sequence and inout of phase fast gradient echo T1 weighted sequences Iron-labeled islets will be visualized as a loss of signal on fast gradient echo T2 weighted sequence and the islet mass will be assessed in a semi-quantitative fashion using a visual scale Finally ultrashort echo time sequences will be used to generate a T2 map The amount of iron contained inside the transplanted islets will be quantified based on the T2 map and the correction for the distribution of the iron particles inside the liver
Monitoring results will be compared to islet function assessed by routine tests exogenous insulin requirement C-peptide HbA1c fructosamine arginine stimulation test Results will be analyzed retrospectively for the first 2 years According to results of the analysis the investigators may decide to intervene proactively ie administer antirejection therapy in the last year of the study whenever results suggestive of a dysfunction are observed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None