Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls
Completed · Phase 1
Conditions studied: Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT01710371
- Run by
- Avid Radiopharmaceuticals
- People needed
- 40
- Starts
- 2012-12-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2015-11-13
Who can join
Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- Healthy Overweight
- Pre-diabetes
- 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.
You may not qualify if…
- 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.
Where it is running
- Research Site — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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