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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Avid Radiopharmaceuticals
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01710371
First received: October 17, 2012
Last updated: September 4, 2014
Last verified: September 2014

October 17, 2012
September 4, 2014
December 2012
August 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 ] [ Designated as safety issue: No ]
  • Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133 [ Time Frame: PET visit 1 ] [ Designated as safety issue: No ]
  • Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133 [ Time Frame: PET visit 1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01710371 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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).
    Interventions:
    • Drug: 18F-AV-133
    • Drug: 10% Arginine Hydrochloride-R-Gene 10
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
August 2015
August 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.
Both
30 Years to 65 Years
Yes
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com
United States
 
NCT01710371
A9001458
No
Avid Radiopharmaceuticals
Avid Radiopharmaceuticals
Pfizer
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
Avid Radiopharmaceuticals
September 2014

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