Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

11C-5-HTP PET in Clinical Islet Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02689479
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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
    Other 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


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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 ]
  3. The relationship between βcell mass calculated from the 11C-5-HTP PET and number of islets transplanted (Total IEQ) [ Time Frame: 8 month ]
  4. 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.

  5. The distribution of fat accumulation in the liver [ Time Frame: 8 month ]
  6. 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 ]
  7. The relationship with PET and peak C-peptide [ Time Frame: 8 month ]
  8. The relationship with PET and C-peptide AUC [ Time Frame: 8 month ]
  9. 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.

  10. The incidence and severity of adverse events related to the PET investigation including allergic reactions [ Time Frame: 8 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Sweden
Karolinska University Hospital
Stockholm, Sweden
Uppsala University
Uppsala, Sweden
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Principal Investigator: Olle Korsgren Uppsala University Hospital
Study Chair: Torbjorn Lundgren, MD Karolinska University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02689479     History of Changes
Other Study ID Numbers: DAIT CIT-09
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Clinical Islet Transplantation
Positron Emission Tomography (PET) Computed Tomography (CT) imaging

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
5-Hydroxytryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs