11C-5-HTP PET in Clinical Islet Transplantation
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|ClinicalTrials.gov Identifier: NCT02689479|
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : February 24, 2016
In people with type I diabetes, the insulin producing cells in the pancreas have been destroyed. Presently one can only evaluate the function of the graft through laboratory tests, blood sugars and the insulin requirements. The mass of the insulin producing cells and their location are not known. The possibility to study the mass of insulin producing cells is of importance when developing new treatment regimes, in order to evaluate their efficacy on this parameter.
The researchers in this study are aiming to develop methods to measure the mass of insulin producing cells. A method (positron emission tomography, PET) previously used for the diagnosis of tumors of insulin producing cells may also be used to measure the amount of insulin producing cells in patients with type I diabetes. They plan to evaluate participants with type 1 diabetes that have undergone islet transplantation, to evaluate if PET can be used to measure the beta cell mass after islet transplantation.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Procedure: Positron-Emission Tomography Biological: 11C-5-HTP Procedure: Magnetic Resonance Imaging Procedure: Mixed-Meal Tolerance Test (MMTT) Procedure: Continuous Glucose Monitoring System® (CGMS) Procedure: Glomerular Filtration Rate Testing Procedure: Blood draw||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Use of 11C-5-HTP PET to Calculate βCell Mass in Clinical Islet Transplantation (DAIT CIT-09)|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
- Procedure: Positron-Emission Tomography
Dynamic scanning is performed for 60 minutes. Image acquisition is performed in 3D and reconstructed using an iterative OSEM VUEPOINT algorithmOther Names:
- Positron Emission Tomography (PET) Imaging
- PET Scan
- Biological: 11C-5-HTP
150-400 MBq [11C]5-HTP (approximately 2-5 MBq/kg) is administered manually as an intravenous bolus in a intravenous catheter in the arm prior to PET imaging.
- Procedure: Magnetic Resonance Imaging
Analysis will focus on adipose tissue distribution and composition in the liver.Other Name: MRI Scans
- Procedure: Mixed-Meal Tolerance Test (MMTT)
- Procedure: Continuous Glucose Monitoring System® (CGMS)
CGMS involves the subcutaneous (SC) placement of a glucose sensor connected by tubing to a pager-sized monitoring device that stores glucose data. Subjects will have the sensor placed in the clinic and wear it continuously for 72 - 84 hours (Gold) or 72-144 hours (iPro2).
- Procedure: Glomerular Filtration Rate Testing
- Procedure: Blood draw
- The relationship between β cell mass calculated from the 11C-5-HTP PET scans and the MMTT C-peptide at 90 minutes [ Time Frame: 8 month ]Regression methods will be used to describe the association between the beta cell mass and 90 minute c-peptide.
- The relationship between βcell mass calculated from the 11C-5-HTP PET and the β-score computed at the time of the PET scan [ Time Frame: 8 month ]Regression methods will also be used to develop models to describe the relationship between the number of islets infused and the islet mass measured by PET.
- The relationship between βcell mass calculated from the 11C-5-HTP PET and CPGCR computed at the time of the PET scan [ Time Frame: 8 month ]
- The relationship between βcell mass calculated from the 11C-5-HTP PET and number of islets transplanted (Total IEQ) [ Time Frame: 8 month ]
- The distribution of islets in the liver [ Time Frame: 8 month ]Descriptive measures and scatterplots will be used to visualize the distribution of beta cells in selected regions of the liver.
- The distribution of fat accumulation in the liver [ Time Frame: 8 month ]
- The relationship between distribution patterns in the liver and MMTT C-peptide at 90 minutes computed at the time of the PET scan [ Time Frame: 8 month ]
- The relationship with PET and peak C-peptide [ Time Frame: 8 month ]
- The relationship with PET and C-peptide AUC [ Time Frame: 8 month ]
- The distribution of islets in the liver related to distribution of fat accumulation in the liver as measured by MRI [ Time Frame: 8 month ]Descriptive measures and scatterplots will be used to visualize the association between beta cells and fat deposits in the liver.
- The incidence and severity of adverse events related to the PET investigation including allergic reactions [ Time Frame: 8 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689479
|Karolinska University Hospital|
|Principal Investigator:||Olle Korsgren||Uppsala University Hospital|
|Study Chair:||Torbjorn Lundgren, MD||Karolinska University Hospital|