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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-AV-133
10% Arginine Hydrochloride-R-Gene 10
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arginine Stimulation Testing

PET Imaging

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133
Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133
Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133

Secondary Outcome Measures

Full Information

First Posted
October 17, 2012
Last Updated
November 12, 2015
Sponsor
Avid Radiopharmaceuticals
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01710371
Brief Title
Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls
Official Title
Quantitative PET Imaging of Pancreatic Beta-Cell Mass in Healthy Overweight/Obese Subjects, Subjects With Prediabetes, and Type 2 Diabetes Patients With 18F-FP-DTBZ (18F-AV-133)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arginine Stimulation Testing
Arm Type
Experimental
Arm Description
Establish the methodology for glucose enhanced arginine stimulation testing (AST).
Arm Title
PET Imaging
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
18F-AV-133
Intervention Description
296 MBq (8 mCi)
Intervention Type
Drug
Intervention Name(s)
10% Arginine Hydrochloride-R-Gene 10
Primary Outcome Measure Information:
Title
Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133
Time Frame
PET visit 1
Title
Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133
Time Frame
PET visit 1
Title
Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133
Time Frame
PET visit 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Healthy Overweight Pre-diabetes 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

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

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