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

Type 2 Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710371
• Other study ID #: A9001458
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2012
• Last updated: November 12, 2015
• Start date: December 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• 18F-AV-133
296 MBq (8 mCi)
• 10% Arginine Hydrochloride-R-Gene 10

Locations

Country	Name	City	State
United States	Research Site	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133		PET visit 1	No
Primary	Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133		PET visit 1	No
Primary	Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133		PET visit 1	No