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

NCT01515384 | Terminated Phase 1

• 1 other identifier: 18F-AV-133-D01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Pancreatic uptake and clearance of 18F-AV-133 tracer as determined by SUVR

  SUVR=standard uptake value ratio

  0-90 minutes

Study Arms (3)

Type 1 Diabetes

EXPERIMENTAL

Drug: 18F-AV-133

Type 2 Diabetes

EXPERIMENTAL

Drug: 18F-AV-133

Healthy Controls

EXPERIMENTAL

Drug: 18F-AV-133

Interventions

18F-AV-133 DRUG

IV injection, 7.6 mCi (281.2 MBq)

Healthy Controls; Type 1 Diabetes; Type 2 Diabetes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Patients with type 1 diabetes may be enrolled if they meet all of the following criteria: * Are males or females between 18 and 70 years of age, inclusive; * Have a diagnosis of type 1 diabetes mellitus as defined by ADA criteria; diabetes onset younger than age 21, duration \>5 years; Insulin dose requirements ≤ 0.8 units/kg/day; * HbA1c level ≥ 5% and ≤ 8%; * Have fasting C-Peptide \< 0.1 ng/ml; * Have a BMI between 18 and 32 kg/m2; * Able to tolerate PET imaging; * In the judgment of the physician, are capable of fasting 4-6 hours prior to screening and Day 1 imaging procedures; and * Give informed consent. Patients with type 2 diabetes may be enrolled if they meet all of the following criteria: * Are males or females between 18 and 70 years of age, inclusive; * Must have been diagnosed with type 2 diabetes for more than five years; * HbA1c level ≥ 5% and ≤ 8%; * Have a BMI between 18 and 32 kg/m2; * Glucose \> 200 mg/dl on Mixed Meal Tolerance Test at screening visit; * Able to tolerate PET imaging; * In the judgment of the physician, are capable of fasting 4-6 hours prior to screening and Day 1 imaging procedures; and * Give informed consent. Healthy volunteers may be enrolled if they meet all of the following criteria: * Are males or females between 18 and 70 years of age, inclusive; * Have no history of type 1 or type 2 diabetes in a first degree relative; * Fasting blood glucose ≤ 100 mg/dL; * HbA1c level ≤ 6%; * Normal Mixed Meal Tolerance test at screening visit; * BMI between 18 and 32 kg/m2; * Able to tolerate PET imaging; * In the judgment of the physician, are capable of fasting 4-6 hours prior to screening and Day 1 imaging procedures; and * Give informed consent. Subjects will be excluded from enrollment if they meet any of the following criteria: * Clinically significant renal dysfunction; * Clinically significant liver dysfunction as determined by history, physical examination, and standard liver function testing at screening (AST, ALT, Total/Direct Bilirubin, Alkaline Phosphatase); * Coagulopathy; * Use medications known to affect dopaminergic function, including MAO inhibitors, tetrabenazine, or levodopa; * Recent (within 3 months) or current treatment with drugs influencing beta cell function or insulin sensitivity (e.g. glucocorticoids, reserpine); * Have polycystic ovarian syndrome; * History of movement disorder such as Parkinson's Disease, Huntington's Disease; * Clinically significant psychiatric disease or history of psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia; * Current use (within past year) of cocaine, methamphetamine, and/or ecstasy ( MDMA, 34- methylenedioxymethamphetamine; * Have a recent history of alcohol or substance abuse or dependence; * Clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG (including but not limited to QTc\>450 msec); * Clinically significant pulmonary, renal or hepatic impairment, or cancer; * Have clinically significant infectious disease, including AIDS or HIV infection or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2; * Are women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using adequate contraception. Women must not be pregnant (negative serum β-HCG at the time of screen) or breastfeeding at screening, and must agree to take appropriate steps not to become pregnant for 30 days following the clinical trial; * Require medications with a narrow therapeutic window (e.g., warfarin), are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days; * Weigh more than the manufacturer-recommended limit for the PET/CT camera being used; * Any prior participation in other research protocols within the past month that involved radiation, with the exception of plain radiography studies (i.e., chest x-rays); and * Have received a diagnostic or therapeutic radiopharmaceutical within the past week.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (1)

Research Site

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

florbenazine F 18

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2011
• First Posted: January 24, 2012
• Study Start: June 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (1)