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

NCT ID: NCT01515384

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-02-28

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. 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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Type 1 Diabetes

Group Type: EXPERIMENTAL

18F-AV-133

Intervention Type: DRUG

IV injection, 7.6 mCi (281.2 MBq)

Type 2 Diabetes

Group Type: EXPERIMENTAL

18F-AV-133

Intervention Type: DRUG

IV injection, 7.6 mCi (281.2 MBq)

Healthy Controls

Group Type: EXPERIMENTAL

18F-AV-133

Intervention Type: DRUG

IV injection, 7.6 mCi (281.2 MBq)

Interventions

18F-AV-133

IV injection, 7.6 mCi (281.2 MBq)

Intervention Type: DRUG

Eligibility Criteria

Exclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Avid Radiopharmaceuticals

Locations

Research Site

New York, New York, United States

Countries

United States

Other Identifiers

18F-AV-133-D01

Identifier Type: -

Identifier Source: org_study_id