Back to results

11C-5-HTP PET in Clinical Islet Transplantation

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Positron-Emission Tomography

11C-5-HTP

Magnetic Resonance Imaging

Mixed-Meal Tolerance Test (MMTT)

Continuous Glucose Monitoring System® (CGMS)

Glomerular Filtration Rate Testing

Blood draw

About this trial

This is an interventional diagnostic trial for Type 1 Diabetes focused on measuring Clinical Islet Transplantation, Positron Emission Tomography (PET) Computed Tomography (CT) imaging

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

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.
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%.
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.
Treatment with any anti-diabetic medication, other than insulin, within 4 weeks of enrollment.
Use of any investigational agents within 4 weeks of enrollment.
Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

Sites / Locations

Karolinska University Hospital
Uppsala University

Outcomes

Primary Outcome Measures

The relationship between β 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.

Secondary Outcome Measures

The relationship between βcell mass calculated from the 11C-5-HTP PET and the β-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.

The relationship between βcell mass calculated from the 11C-5-HTP PET and CPGCR computed at the time of the PET scan

The relationship between βcell mass calculated from the 11C-5-HTP PET and number of islets transplanted (Total IEQ)

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.

The distribution of fat accumulation in the liver

The relationship between distribution patterns in the liver and MMTT C-peptide at 90 minutes computed at the time of the PET scan

The relationship with PET and peak C-peptide

The relationship with PET and C-peptide AUC

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.

The incidence and severity of adverse events related to the PET investigation including allergic reactions

Full Information

NCT ID

NCT02689479

First Posted

February 22, 2016

Last Updated

February 22, 2016

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT02689479

Brief Title

11C-5-HTP PET in Clinical Islet Transplantation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Clinical Islet Transplantation, Positron Emission Tomography (PET) Computed Tomography (CT) imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Positron-Emission Tomography

Other Intervention Name(s)

Positron Emission Tomography (PET) Imaging, PET Scan

Intervention Description

Dynamic scanning is performed for 60 minutes. Image acquisition is performed in 3D and reconstructed using an iterative OSEM VUEPOINT algorithm

Intervention Type

Biological

Intervention Name(s)

11C-5-HTP

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Imaging

Other Intervention Name(s)

MRI Scans

Intervention Description

Analysis will focus on adipose tissue distribution and composition in the liver.

Intervention Type

Procedure

Intervention Name(s)

Mixed-Meal Tolerance Test (MMTT)

Intervention Type

Procedure

Intervention Name(s)

Continuous Glucose Monitoring System® (CGMS)

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

Glomerular Filtration Rate Testing

Intervention Type

Procedure

Intervention Name(s)

Blood draw

Primary Outcome Measure Information:

Title

The relationship between β cell mass calculated from the 11C-5-HTP PET scans and the MMTT C-peptide at 90 minutes

Description

Regression methods will be used to describe the association between the beta cell mass and 90 minute c-peptide.

Time Frame

8 month

Secondary Outcome Measure Information:

Title

The relationship between βcell mass calculated from the 11C-5-HTP PET and the β-score computed at the time of the PET scan

Description

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.

Time Frame

8 month

Title

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

Title

The relationship between βcell mass calculated from the 11C-5-HTP PET and number of islets transplanted (Total IEQ)

Time Frame

8 month

Title

The distribution of islets in the liver

Description

Descriptive measures and scatterplots will be used to visualize the distribution of beta cells in selected regions of the liver.

Time Frame

8 month

Title

The distribution of fat accumulation in the liver

Time Frame

8 month

Title

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

Title

The relationship with PET and peak C-peptide

Time Frame

8 month

Title

The relationship with PET and C-peptide AUC

Time Frame

8 month

Title

The distribution of islets in the liver related to distribution of fat accumulation in the liver as measured by MRI

Description

Descriptive measures and scatterplots will be used to visualize the association between beta cells and fat deposits in the liver.

Time Frame

8 month

Title

The incidence and severity of adverse events related to the PET investigation including allergic reactions

Time Frame

8 month

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must meet all of the following criteria to be considered eligible for participation in the study: Subjects who are able to provide written informed consent and comply with the procedures of the study protocol. 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: 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. Known history of severe co-existing cardiac disease, characterized by any one of the following conditions: Recent myocardial infarction (within past 6 months). Evidence of ischemia on functional cardiac exam within the last year. Left ventricular ejection fraction <30%. 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. Treatment with any anti-diabetic medication, other than insulin, within 4 weeks of enrollment. Use of any investigational agents within 4 weeks of enrollment. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olle Korsgren

Organizational Affiliation

Uppsala University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Torbjorn Lundgren, MD

Organizational Affiliation

Karolinska University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Karolinska University Hospital

City

Stockholm

Country

Sweden

Facility Name

Uppsala University

City

Uppsala

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

27325286

Citation

Eriksson O, Selvaraju R, Eich T, Willny M, Brismar TB, Carlbom L, Ahlstrom H, Tufvesson G, Lundgren T, Korsgren O. Positron Emission Tomography to Assess the Outcome of Intraportal Islet Transplantation. Diabetes. 2016 Sep;65(9):2482-9. doi: 10.2337/db16-0222. Epub 2016 Jun 20.

Results Reference

derived

Links:

URL

https://www.niaid.nih.gov/Pages/default.aspx

Description

National Institute of Allergy and Infectious Diseases (NIAID)

Learn more about this trial

11C-5-HTP PET in Clinical Islet Transplantation

We'll reach out to this number within 24 hrs