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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01710371
Recruitment Status : Completed
First Posted : October 19, 2012
Last Update Posted : November 13, 2015
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

October 17, 2012
October 19, 2012
November 13, 2015
December 2012
September 2015   (Final data collection date for primary outcome measure)
  • Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133 [ Time Frame: PET visit 1 ]
  • Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133 [ Time Frame: PET visit 1 ]
  • Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133 [ Time Frame: PET visit 1 ]
Same as current
Complete list of historical versions of study NCT01710371 on Archive Site
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Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls
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)
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.
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Type 2 Diabetes
  • Drug: 18F-AV-133
    296 MBq (8 mCi)
  • Drug: 10% Arginine Hydrochloride-R-Gene 10
  • Experimental: Arginine Stimulation Testing
    Establish the methodology for glucose enhanced arginine stimulation testing (AST).
    Intervention: Drug: 10% Arginine Hydrochloride-R-Gene 10
  • Experimental: PET Imaging
    Determine if pancreatic PET-determined binding measures of 18F-AV-133 differ in up to 60 subjects determined to be at one of four stages of the natural history of Type 2 Diabetes: Healthy Overweight/obese Volunteers (HOV), Subjects with Pre-diabetes (PD) and Type 2 Diabetes mellitus (T2DM).
    • Drug: 18F-AV-133
    • Drug: 10% Arginine Hydrochloride-R-Gene 10
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2015
September 2015   (Final data collection date for primary outcome measure)

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

    1. Healthy Overweight
    2. Pre-diabetes
    3. 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.
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Avid Radiopharmaceuticals
Avid Radiopharmaceuticals
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
Avid Radiopharmaceuticals
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP