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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01710371

Enrollment

Registered

2012-10-19

Start date

2012-12-31

Completion date

2015-09-30

Last updated

2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

DRUG18F-AV-133

296 MBq (8 mCi)

DRUG10% Arginine Hydrochloride-R-Gene 10

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133	PET visit 1
Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133	PET visit 1
Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133	PET visit 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026