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

Type 2 Diabetes Clinical Trial

Official title:

A Preliminary Evaluation of the Safety and Pancreas Imaging Properties of 18F-AV-133 in Healthy Volunteers and in Patients With Type 1 or Type 2 Diabetes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01515384
• Other study ID #: 18F-AV-133-D01
• Status: Terminated
• Phase: Phase 1
• Start date: June 2010
• Est. completion date: February 2013

Study information

• Verified date: January 2020
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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. Specifically, this study will evaluate 18F-AV-133 imaging in patients with type 1 diabetes, patients with type 2 diabetes and in healthy controls in order to:

1. Obtain information regarding the safety of 18F-AV-133 in these populations;

2. Determine whether uptake, distribution, or clearance of 18F-AV-133 in the pancreas differs between subjects with predicted reduced beta cell mass (patients with type 1 or type 2 diabetes of long duration) and normal beta cell mass (healthy volunteers);

3. Evaluate the PET imaging pharmacokinetics of 18F-AV-133 in abdominal organs of healthy control subjects and patients with type 1 or type 2 diabetes;

4. Obtain preliminary information regarding the appropriate time window for optimal PET imaging of 18F-AV-133 in the pancreas post-administration for type 1, type 2, and normal healthy individuals;

5. Obtain preliminary information regarding an appropriate reference tissue for evaluating the PET imaging results of 18F-AV-133 in the pancreas; and

6. Evaluate the imaging properties of 18F-AV-133 in the pancreas relative to the brain in a subset of subjects.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Drug:
• 18F-AV-133
IV injection, 7.6 mCi (281.2 MBq)

Locations

Country	Name	City	State
United States	Research Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic uptake and clearance of 18F-AV-133 tracer as determined by SUVR	SUVR=standard uptake value ratio	0-90 minutes