11C-5-HTP PET in Clinical Islet Transplantation

February 22, 2016 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital
      • Uppsala, Sweden
        • Uppsala University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 month
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
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
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.
8 month
The distribution of fat accumulation in the liver
Time Frame: 8 month
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
8 month
The relationship with PET and peak C-peptide
Time Frame: 8 month
8 month
The relationship with PET and C-peptide AUC
Time Frame: 8 month
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.
8 month
The incidence and severity of adverse events related to the PET investigation including allergic reactions
Time Frame: 8 month
8 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Olle Korsgren, Uppsala University Hospital
  • Study Chair: Torbjörn Lundgren, MD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT CIT-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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