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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01515384
First received: February 21, 2011
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Type 1 Diabetes
Type 2 Diabetes
Drug: 18F-AV-133
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Preliminary Evaluation of the Safety and Pancreas Imaging Properties of 18F-AV-133 in Healthy Volunteers and in Patients With Type 1 or Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Pancreatic uptake and clearance of 18F-AV-133 tracer as determined by SUVR [ Time Frame: 0-90 minutes ] [ Designated as safety issue: No ]
    SUVR=standard uptake value ratio


Estimated Enrollment: 35
Study Start Date: June 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Type 1 Diabetes Drug: 18F-AV-133
IV injection, 7.6 mCi (281.2 MBq)
Experimental: Type 2 Diabetes Drug: 18F-AV-133
IV injection, 7.6 mCi (281.2 MBq)
Experimental: Healthy Controls Drug: 18F-AV-133
IV injection, 7.6 mCi (281.2 MBq)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515384

Locations
United States, New York
Research Site
New York, New York, United States, 10027
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01515384     History of Changes
Other Study ID Numbers: 18F-AV-133-D01
Study First Received: February 21, 2011
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014