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Positron Emission Tomography (PET) Imaging of Pancreatic Beta-Cell Mass in Healthy and Type 1 Diabetic Patients

NCT00958997 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2012-07-23

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

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

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).

BIOLOGICAL

Arginine-hydrochloride

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Avid Radiopharmaceuticals

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Gary W Cline, Ph.D. · Yale University

  • Yu-Shin Ding, Ph.D. · Yale University

  • Kitt F Petersen, M.D. · Yale University

  • Richard Carson, Ph.D. · Yale University

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-10-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00958997 on ClinicalTrials.gov