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

NCT01710371 | Completed Phase 1

• 1 other identifier: A9001458
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133

  PET visit 1

• Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133

  PET visit 1

• Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133

  PET visit 1

Study Arms (2)

Arginine Stimulation Testing

EXPERIMENTAL

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

Drug: 10% Arginine Hydrochloride-R-Gene 10

PET Imaging

EXPERIMENTAL

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).

Drug: 18F-AV-133; Drug: 10% Arginine Hydrochloride-R-Gene 10

Interventions

18F-AV-133 DRUG

296 MBq (8 mCi)

PET Imaging

10% Arginine Hydrochloride-R-Gene 10 DRUG

Arginine Stimulation Testing; PET Imaging

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Healthy Overweight
• Pre-diabetes
• T2DM

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead
• Pfizer: collaborator

Study Sites (1)

Research Site

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

florbenazine F 18

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 19, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

US (1)