A Trial of 18F-AV-133 Positron Emission Tomography (PET)

Phase 1

Terminated

• Conditions: Type 1 Diabetes; Type 2 Diabetes
• Interventions: Drug: 18F-AV-133

• Registration Number: NCT01515384
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

The purpose of this study is to evaluate the safety and pancreas imaging properties of 18F-AV-133.

Detailed Description

The primary objective of this protocol is to address the feasibility for further development of the VMAT2-binding compound 18F-AV-133 as a diagnostic radiopharmaceutical in the field of diabetes. Specifically, this study will evaluate 18F-AV-133 imaging in patients with type 1 diabetes, patients with type 2 diabetes and in healthy controls in order to:

1. Obtain information regarding the safety of 18F-AV-133 in these populations;

2. Determine whether uptake, distribution, or clearance of 18F-AV-133 in the pancreas differs between subjects with predicted reduced beta cell mass (patients with type 1 or type 2 diabetes of long duration) and normal beta cell mass (healthy volunteers);

3. Evaluate the PET imaging pharmacokinetics of 18F-AV-133 in abdominal organs of healthy control subjects and patients with type 1 or type 2 diabetes;

4. Obtain preliminary information regarding the appropriate time window for optimal PET imaging of 18F-AV-133 in the pancreas post-administration for type 1, type 2, and normal healthy individuals;

5. Obtain preliminary information regarding an appropriate reference tissue for evaluating the PET imaging results of 18F-AV-133 in the pancreas; and

6. Evaluate the imaging properties of 18F-AV-133 in the pancreas relative to the brain in a subset of subjects.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-24
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Type 1 Diabetes	18F-AV-133	-
Type 2 Diabetes	18F-AV-133	-
Healthy Controls	18F-AV-133	-

Primary Outcome Measures

Name	Time	Method
Pancreatic uptake and clearance of 18F-AV-133 tracer as determined by SUVR	0-90 minutes	SUVR=standard uptake value ratio

Trial Locations

Locations (1)

Research Site; 🇺🇸 New York, New York, United States