Status:
TERMINATED
A Trial of 18F-AV-133 Positron Emission Tomography (PET)
Lead Sponsor:
Avid Radiopharmaceuticals
Conditions:
Type 1 Diabetes
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and pancreas imaging properties of 18F-AV-133.
Detailed Description
The primary objective of this protocol is to address the feasibility for further development of the VMAT2-binding compound 18F-AV-133 as a diagnostic radiopharmaceutical in the field of diabetes. Spec...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01515384
Start Date
June 1 2010
End Date
February 1 2013
Last Update
January 13 2020
Active Locations (1)
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1
Research Site
New York, New York, United States, 10027