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

NCT01710371

Last updated date
Study Location
Research Site
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: 18F-AV-133
    296 MBq (8 mCi)
  • Drug: 10% Arginine Hydrochloride-R-Gene 10
Study Arms  ICMJE
  • Experimental: Arginine Stimulation Testing
    Establish the methodology for glucose enhanced arginine stimulation testing (AST).
    Intervention: 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) and Type 2 Diabetes mellitus (T2DM).
    Interventions:
    • Drug: 18F-AV-133
    • Drug: 10% Arginine Hydrochloride-R-Gene 10
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2015)
40
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2012)
68
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01710371
Other Study ID Numbers  ICMJE A9001458
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avid Radiopharmaceuticals
Study Sponsor  ICMJE Avid Radiopharmaceuticals
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Chief Medical OfficerAvid Radiopharmaceuticals
PRS Account Avid Radiopharmaceuticals
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP