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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: 18F-AV-133 Drug: 10% Arginine Hydrochloride-R-Gene 10 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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)
Study Start Date : December 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arginine Stimulation Testing
Establish the methodology for glucose enhanced arginine stimulation testing (AST).
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
296 MBq (8 mCi)

Drug: 10% Arginine Hydrochloride-R-Gene 10

Primary Outcome Measures :
  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 ]

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01710371

United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Avid Radiopharmaceuticals
Study Director: Chief Medical Officer Avid Radiopharmaceuticals

Responsible Party: Avid Radiopharmaceuticals Identifier: NCT01710371     History of Changes
Other Study ID Numbers: A9001458
First Posted: October 19, 2012    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases