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CompletedNCT01710371Updated Nov 13, 2015

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

A Phase 1 interventional study of 18F-AV-133 and 10% Arginine Hydrochloride-R-Gene 10 in Type 2 Diabetes, sponsored by Avid Radiopharmaceuticals. Completed at 1 site in United States. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-13.

Sponsored by Avid Radiopharmaceuticals · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
30 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Avid Radiopharmaceuticals is the lead sponsor of 54 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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 · Drug: 10% Arginine Hydrochloride-R-Gene 10

Interventions

  • Drug18F-AV-133

    296 MBq (8 mCi)

  • Drug10% Arginine Hydrochloride-R-Gene 10
06

What researchers measure

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

07

Study locations

1 site
  • Research Site
    New Haven, Connecticut 06511, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01710371
Lead sponsor
Avid Radiopharmaceuticals
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Oct 19, 2012
Start date
Dec 2012
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Nov 13, 2015

Study contacts

Chief Medical Officer
study director · Avid Radiopharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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