Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014