Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls

NCT ID: NCT01710371

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-09-30

Brief Summary

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.

Conditions

Type 2 Diabetes

Study Design

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

Study Groups

Arginine Stimulation Testing

Establish the methodology for glucose enhanced arginine stimulation testing (AST).

Group Type: EXPERIMENTAL

10% Arginine Hydrochloride-R-Gene 10

Intervention Type: DRUG

PET Imaging

Determine if pancreatic PET-determined binding measures of 18F-AV-133 differ in up to 60 subjects determined to be at one of four stages of the natural history of Type 2 Diabetes: Healthy Overweight/obese Volunteers (HOV), Subjects with Pre-diabetes (PD) and Type 2 Diabetes mellitus (T2DM).

Group Type: EXPERIMENTAL

18F-AV-133

Intervention Type: DRUG

296 MBq (8 mCi)

10% Arginine Hydrochloride-R-Gene 10

Intervention Type: DRUG

Interventions

18F-AV-133

296 MBq (8 mCi)

Intervention Type: DRUG

10% Arginine Hydrochloride-R-Gene 10

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

1. Healthy Overweight

2. Pre-diabetes

3. 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

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 Haven, Connecticut, United States

Countries

United States

Other Identifiers

A9001458

Identifier Type: -

Identifier Source: org_study_id