CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
18F-FP-DTBZ (18F-AV-133) +1 moredrug
Likely dose
18F-FP-DTBZ (18F-AV-133) 25 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00958997
NCT00958997N/ACompleted

Quantitative PET Imaging of Pancreatic Beta-cell Mass in Healthy and Type 1 Diabetic Patients With 18F-FP-DTBZ (AV-133)

Yale University·observational·Posted Aug 14, 2009·Updated Jul 23, 2012

In Brief

An observational study evaluating 18F-FP-DTBZ (18F-AV-133) and Arginine-hydrochloride for Diabetes Mellitus, Type 1. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Pancreatic Islet beta-cells are responsible for synthesizing and secreting appropriate amounts of insulin to regulate blood glucose levels. One factor in the development of diabetes is the loss of beta-cells. Developing treatments to prevent or restore islet beta-cell mass (BCM) in diabetic patients is hampered by a lack of methods for the non-invasive imaging of these cells. This study is designed to evaluate a radiolabeled compound that binds to the pancreatic islet. The investigators will test the ability of one promising imaging compound, 18F-9-fluoropropyl-(+)-dihydrotetrabenazine (18F-FP-DTBZ), to measure the amount of pancreatic islet beta-cells in patients with long-standing type-1 diabetes and in age-weight-matched healthy control subjects.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 14, 2009
Enrollment StartAug 1, 2009
Primary CompletionOct 1, 2011
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.9 years ago

Interventions

18F-FP-DTBZ (18F-AV-133)drug

The subjects will receive a single IV bolus of approximately 10 mCi 18F-AV-133.(Injection will contain no more than 25 µg of non-radiolabeled 19F-AV-133).

Arginine-hydrochloridebiological

A bolus injection of 5g of 10% arginine-hydrochloride will be given over a period of 1 minute.