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NCT02236754 · ClinicalTrials.gov registry record · Early Phase 1
Evaluation of 18 F-FP-DTBZ Pancreatic PET Scanning as a Tool to Measure Beta Cell Mass
A Early Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 23
- Enrollment target
NCT02236754 is a Early Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 23 participants.
The verdict
NCT02236754, a Early Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 23 participants
- Enrollment target
Study 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.
Interventions
- DRUG 18 F-FP-DTBZ
- RADIATION PET Scanning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-07-02 |
| Est. Completion | 2014-04-23 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02236754
The ClinicalTrials.gov registry entry for NCT02236754 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 18 F-FP-DTBZ is the first listed.
NCT02236754 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02236754 about?
NCT02236754 is a clinical study titled "Evaluation of 18 F-FP-DTBZ Pancreatic PET Scanning as a Tool to Measure Beta Cell Mass". 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 t...
What is the current status of trial NCT02236754?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 23 participants. The study started on 2013-07-02. Estimated completion is 2014-04-23.
What interventions are being tested in trial NCT02236754?
The interventions under investigation include: 18 F-FP-DTBZ (DRUG), PET Scanning (RADIATION).
Who is sponsoring clinical trial NCT02236754?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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