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Completed

NCT Number: NCT01710371

Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls

To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects. These subjects will also be evaluated for beta-cell function as measured by the insulin and C-peptide response to a challenge with intravenous arginine under basal and glucose enhanced conditions.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and/or female subjects of non-childbearing potential between the ages of 30 and 65 years inclusive.
  • Able to tolerate PET, PET/CT and MR imaging
  • Estimated creatinine clearance >= 60mL/min
  • Informed consent documents signed and dated by subject
  • Subjects must be willing and able to comply with all scheduled visits, treatments laboratory tests, scans and other study procedures.
  • In addition, subjects must meet classification requirements for one of the following
  • Healthy Overweight
  • Pre-diabetes
  • T2DM
  • (T2DM only) Subjects with other chronic medical conditions (besides diabetes) that are well controlled and stable on medication are acceptable for inclusion in this study.

Exclusion criteria

  • Subjects who are affiliated with or relatives of staff members of either the site or Pfizer directly involved in the conduct of the trial.
  • Conditions which in the opinion of the study investigator may interfere with the subject's ability to participate in the study
  • History of allergic reaction to drug/contrast agent or history of drug/alcohol abuse
  • Subjects who have received investigational medications within the last 30 days or a radiopharmaceutical in the past 7 days.
  • Pregnant or nursing females; females of childbearing potential.

Treatment and study plan

18F-AV-133

Drug

296 MBq (8 mCi)

10% Arginine Hydrochloride-R-Gene 10

Drug

Primary outcomes

  1. Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133

    Time frame: PET visit 1

  2. Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133

    Time frame: PET visit 1

  3. Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133

    Time frame: PET visit 1

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Collaborators

  • Pfizer

Registry information

Official study title

Quantitative PET Imaging of Pancreatic Beta-Cell Mass in Healthy Overweight/Obese Subjects, Subjects With Prediabetes, and Type 2 Diabetes Patients With 18F-FP-DTBZ (18F-AV-133)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 19, 2012
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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