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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Avid Radiopharmaceuticals
• Collaborator: Pfizer

Criteria

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.