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

This study is currently recruiting participants.
Verified February 2013 by Avid Radiopharmaceuticals
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01710371
First received: October 17, 2012
Last updated: February 1, 2013
Last verified: February 2013
  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 2014
Estimated Primary Completion Date: August 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01710371

Contacts
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

Locations
United States, Connecticut
Research Site Recruiting
New Haven, Connecticut, United States, 06511
Contact: New Haven 24 Hour Phoneline    203-401-0300      
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: February 1, 2013
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 April 15, 2014