Clinical trial NCT02689479: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Clinical Islet Transplantation
Positron Emission Tomography (PET) Computed Tomography (CT) imaging
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2016-02-24
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: The relationship between β cell mass calculated from the 11C-5-HTP PET scans and the MMTT C-peptide at 90 minutes
timeFrame: 8 month
Secondary outcomes:
measure: The relationship between βcell mass calculated from the 11C-5-HTP PET and the β-score computed at the time of the PET scan
timeFrame: 8 month
measure: The relationship between βcell mass calculated from the 11C-5-HTP PET and CPGCR computed at the time of the PET scan
timeFrame: 8 month
measure: The relationship between βcell mass calculated from the 11C-5-HTP PET and number of islets transplanted (Total IEQ)
timeFrame: 8 month
measure: The distribution of islets in the liver
timeFrame: 8 month
measure: The distribution of fat accumulation in the liver
timeFrame: 8 month
measure: The relationship between distribution patterns in the liver and MMTT C-peptide at 90 minutes computed at the time of the PET scan
timeFrame: 8 month
measure: The relationship with PET and peak C-peptide
timeFrame: 8 month
measure: The relationship with PET and C-peptide AUC
timeFrame: 8 month
measure: The distribution of islets in the liver related to distribution of fat accumulation in the liver as measured by MRI
timeFrame: 8 month
measure: The incidence and severity of adverse events related to the PET investigation including allergic reactions
timeFrame: 8 month
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University Hospital
name: Olle Korsgren
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Torbjorn Lundgren, MD
role: STUDY_CHAIR
References:
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.