A Trial of 18F-AV-133 Positron Emission Tomography (PET)

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and pancreas imaging properties of 18F-AV-133.

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

Details

• Lead Sponsor: Avid Radiopharmaceuticals

Criteria

Patients with type 1 diabetes may be enrolled if they meet all of the following criteria:

• Are males or females between 18 and 70 years of age, inclusive;

• Have a diagnosis of type 1 diabetes mellitus as defined by ADA criteria; diabetes onset younger than age 21, duration >5 years; Insulin dose requirements ≤ 0.8 units/kg/day;

• HbA1c level ≥ 5% and ≤ 8%;

• Have fasting C-Peptide < 0.1 ng/ml;

• Have a BMI between 18 and 32 kg/m2;

• Able to tolerate PET imaging;

• In the judgment of the physician, are capable of fasting 4-6 hours prior to screening and Day 1 imaging procedures; and

• Give informed consent.

Patients with type 2 diabetes may be enrolled if they meet all of the following criteria:

• Are males or females between 18 and 70 years of age, inclusive;

• Must have been diagnosed with type 2 diabetes for more than five years;

• HbA1c level ≥ 5% and ≤ 8%;

• Have a BMI between 18 and 32 kg/m2;

• Glucose > 200 mg/dl on Mixed Meal Tolerance Test at screening visit;

• Able to tolerate PET imaging;

• In the judgment of the physician, are capable of fasting 4-6 hours prior to screening and Day 1 imaging procedures; and

• Give informed consent.

Healthy volunteers may be enrolled if they meet all of the following criteria:

• Are males or females between 18 and 70 years of age, inclusive;

• Have no history of type 1 or type 2 diabetes in a first degree relative;

• Fasting blood glucose ≤ 100 mg/dL;

• HbA1c level ≤ 6%;

• Normal Mixed Meal Tolerance test at screening visit;

• BMI between 18 and 32 kg/m2;

• Able to tolerate PET imaging;

• In the judgment of the physician, are capable of fasting 4-6 hours prior to screening and Day 1 imaging procedures; and

• Give informed consent.

Subjects will be excluded from enrollment if they meet any of the following criteria:

• Clinically significant renal dysfunction;

• Clinically significant liver dysfunction as determined by history, physical examination, and standard liver function testing at screening (AST, ALT, Total/Direct Bilirubin, Alkaline Phosphatase);

• Coagulopathy;

• Use medications known to affect dopaminergic function, including MAO inhibitors, tetrabenazine, or levodopa;

• Recent (within 3 months) or current treatment with drugs influencing beta cell function or insulin sensitivity (e.g. glucocorticoids, reserpine);

• Have polycystic ovarian syndrome;

• History of movement disorder such as Parkinson's Disease, Huntington's Disease;

• Clinically significant psychiatric disease or history of psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia;

• Current use (within past year) of cocaine, methamphetamine, and/or ecstasy ( MDMA, 34- methylenedioxymethamphetamine;

• Have a recent history of alcohol or substance abuse or dependence;

• Clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG (including but not limited to QTc>450 msec);

• Clinically significant pulmonary, renal or hepatic impairment, or cancer;

• Have clinically significant infectious disease, including AIDS or HIV infection or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2;

• Are women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using adequate contraception. Women must not be pregnant (negative serum β-HCG at the time of screen) or breastfeeding at screening, and must agree to take appropriate steps not to become pregnant for 30 days following the clinical trial;

• Require medications with a narrow therapeutic window (e.g., warfarin), are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;

• Weigh more than the manufacturer-recommended limit for the PET/CT camera being used;

• Any prior participation in other research protocols within the past month that involved radiation, with the exception of plain radiography studies (i.e., chest x-rays); and

• Have received a diagnostic or therapeutic radiopharmaceutical within the past week.