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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01710371
First received: October 17, 2012
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: 18F-AV-133
Drug: 10% Arginine Hydrochloride-R-Gene 10
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133 [ Time Frame: PET visit 1 ] [ Designated as safety issue: No ]
  • Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133 [ Time Frame: PET visit 1 ] [ Designated as safety issue: No ]
  • Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133 [ Time Frame: PET visit 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: December 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arginine Stimulation Testing
Establish the methodology for glucose enhanced arginine stimulation testing (AST).
Drug: 10% Arginine Hydrochloride-R-Gene 10
Experimental: 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), Early Type 2 Diabetes mellitus (E-T2DM) and Late Type 2 Diabetes mellitus (L-T2DM)
Drug: 18F-AV-133
296 MBq (8 mCi)
Drug: 10% Arginine Hydrochloride-R-Gene 10

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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. E-T2DM
    4. L-T2DM
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710371

Locations
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Avid Radiopharmaceuticals
Pfizer
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01710371     History of Changes
Other Study ID Numbers: A9001458
Study First Received: October 17, 2012
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014