Early Phase 1
N=23
Evaluation of 18 F-FP-DTBZ Pancreatic PET Scanning as a Tool to Measure Beta Cell Mass
Healthy Volunteers · Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT02236754 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Mean VMAT2 Functional Binding Capacity in the β Cells to 18 F-FP-DTBZ — 103; 38 unitless
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- 18 F-FP-DTBZ (Drug); PET Scanning (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean VMAT2 Functional Binding Capacity in the β Cells to 18 F-FP-DTBZ |
103; 38 | — |
Summary
Type 1 diabetes mellitus (T1DM) develops when there is impaired insulin production due to loss of insulin producing cells (beta cells). The amount of insulin that can be produced is imperfectly correlated with beta cell mass (BCM). The development of a reliable method to noninvasively quantify the total amount of insulin producing beta cells would be of great benefit by providing an important endpoint for the development of new treatments of diabetes. The investigators have previously identified a specific marker on islet cells called vesicular monoamine transporter 2 (VMAT2) that the investigators now propose to use in positron emission tomography (PET) scanning to determine islet beta cell mass. The PET radiopharmaceutical 18 F-fluoropropyl(FP)-dihydrotetrabenazine(DTBZ) has been used previously in human subjects without adverse effects. It has shown promise in differentiating type 1 diabetes and non-diabetes. The investigators now hypothesize that repeat PET scans will be reproducible in the same subject. Subjects with normal BCM will be recruited from among normal weight non-diabetic people with plasma insulin levels within the normal range. Subjects with predicted reduced BCM will be recruited from among patients with T1DM who have low or non-measurable insulin levels. Two PET scan measurements will be taken in each subject and the amount of VMAT2 in the pancreas will be and compared for reproducible findings. Biochemical testing will also be performed and compared to PET scans as a potential indirect marker of beta cell mass.
Eligibility Criteria
Inclusion Criteria
- Patients with type 1 diabetes may be enrolled if they meet all of the following criteria:
- Are males or females between 18 and 70 years of age, inclusive
- Have a diagnosis of type 1 diabetes mellitus as defined by the American Diabetes Association (ADA) criteria or by diagnosed as per their endocrinologist; duration >5 years; Insulin dose requirements 450 msec)
- Clinically significant pulmonary, renal or hepatic impairment, or cancer
- Have clinically significant infectious disease, including acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection or previous positive test for hepatitis B, hepatitis C, or HIV.
- Are women of childbearing potential not refraining from sexual activity or not using adequate contraception.
Women must not be pregnant (negative serum human chorionic gonadotropin (hCG) at the time of screen) or breastfeeding at screening, and must agree to take appropriate steps not to become pregnant during for 30 days following the clinical trial
- Require medications with a narrow therapeutic window (e.g., warfarin), are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
- Weigh more than the manufacturer recommended limit for the PET/computed tomography (CT) camera being used
- Any prior participation in other research protocols within the past month that involved radiation, with the exception of plain radiography studies (i.e., chest x-rays); And
- Have received a diagnostic or therapeutic radiopharmaceutical within the past week
Data sourced from ClinicalTrials.gov (NCT02236754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.