Evaluation of 18F-FP-DTBZ Pancreatic PET Scanning as a Tool to Measure Beta Cell Mass
Status:
Withdrawn
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
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 18F-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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Columbia University
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)