11C-5-HTP PET in Clinical Islet Transplantation

Type 1 Diabetes Clinical Trial

Official title:

Evaluation of the Use of 11C-5-HTP PET to Calculate βCell Mass in Clinical Islet Transplantation (DAIT CIT-09)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689479
• Other study ID #: DAIT CIT-09
• Status: Completed
• Phase: N/A
• First received: February 22, 2016
• Last updated: February 22, 2016
• Start date: May 2013
• Est. completion date: September 2014

Study information

• Verified date: February 2016
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Data and Safety Monitoring BoardSweden: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Subjects must meet all of the following criteria to be considered eligible for participation in the study:

1. Subjects who are able to provide written informed consent and comply with the procedures of the study protocol.

2. Patient that has received an islet transplant in or outside the CIT01 trial (post primary endpoint).

Exclusion Criteria:

Subjects who meet any of these criteria are not eligible for participation in the study:

1. For female subjects: Positive serum pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures at the time of PET scan +/- 2 weeks.

2. Known history of severe co-existing cardiac disease, characterized by any one of the following conditions:

1. Recent myocardial infarction (within past 6 months).

2. Evidence of ischemia on functional cardiac exam within the last year.

3. Left ventricular ejection fraction <30%.

3. Persistent elevation of liver function tests at the time of study entry. Persistent Aspartate Aminotransferase (serum glutamic-oxaloacetic transaminase), Alanine Aminotransferase (serum glutamate pyruvate transaminase), Alkaline phosphatase or total bilirubin, with values >1.5 times normal upper limits will exclude a patient.

4. Treatment with any anti-diabetic medication, other than insulin, within 4 weeks of enrollment.

5. Use of any investigational agents within 4 weeks of enrollment.

6. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Procedure:
• Positron-Emission Tomography
Dynamic scanning is performed for 60 minutes. Image acquisition is performed in 3D and reconstructed using an iterative OSEM VUEPOINT algorithm

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.
• Mixed-Meal Tolerance Test (MMTT)

• 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).
• Glomerular Filtration Rate Testing

• Blood draw

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm
Sweden	Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relationship between ß cell mass calculated from the 11C-5-HTP PET scans and the MMTT C-peptide at 90 minutes	Regression methods will be used to describe the association between the beta cell mass and 90 minute c-peptide.	8 month	No
Secondary	The relationship between ßcell mass calculated from the 11C-5-HTP PET and the ß-score computed at the time of the PET scan	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.	8 month	No
Secondary	The relationship between ßcell mass calculated from the 11C-5-HTP PET and CPGCR computed at the time of the PET scan		8 month	No
Secondary	The relationship between ßcell mass calculated from the 11C-5-HTP PET and number of islets transplanted (Total IEQ)		8 month	No
Secondary	The distribution of islets in the liver	Descriptive measures and scatterplots will be used to visualize the distribution of beta cells in selected regions of the liver.	8 month	No
Secondary	The distribution of fat accumulation in the liver		8 month	No
Secondary	The relationship between distribution patterns in the liver and MMTT C-peptide at 90 minutes computed at the time of the PET scan		8 month	No
Secondary	The relationship with PET and peak C-peptide		8 month	No
Secondary	The relationship with PET and C-peptide AUC		8 month	No
Secondary	The distribution of islets in the liver related to distribution of fat accumulation in the liver as measured by MRI	Descriptive measures and scatterplots will be used to visualize the association between beta cells and fat deposits in the liver.	8 month	No
Secondary	The incidence and severity of adverse events related to the PET investigation including allergic reactions		8 month	Yes

External Links

•   National Institute of Allergy and Infectious Diseases (NIAID)