A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of CardioPET™ as a PET Tracer for Detection of Coronary Artery Disease
Overview
- Phase
- Phase 1
- Intervention
- CardioPET
- Conditions
- Coronary Artery Disease
- Sponsor
- Fluoropharma, Inc.
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85. Nine normal controls will undergo repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging only.
Detailed Description
CardioPET™ is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body. Study Procedures: Visit 1: Screening - Eligibility determination Visit 2: Injection and PET Imaging Visit 3: Follow-up Visit
Investigators
Eligibility Criteria
Inclusion Criteria
- •Normal Healthy Volunteers:
- •Subject must provide written informed consent prior to any study related procedures
- •Subjects must be between the ages of 50 and 85 years of age.
- •Coronary Artery Disease (CAD) subjects:
- •Subjects must provide written informed consent prior to any study related procedures;
- •Subjects must be ≥ 50 and ≤ 85 years of age;
- •Subject must have history of CAD documented by an exercise stress Myocardial Perfusion Imaging (MPI) study within 6 months documenting myocardial infarct without ischemia.
Exclusion Criteria
- •Normal Healthy Volunteers:
- •Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
- •Any clinically significant abnormality in the screening laboratory tests or ECG
- •Fasting blood glucose level over 120 mg/dl
- •Any exposure to any investigational drugs with four(4)weeks prior to Visit 1
- •Any exposure to radiopharmaceuticals within four(4)weeks prior to the date of Visit 1
- •Any new prescription medications within four(4)weeks of Visit 1
- •Subject has a Positive(+)Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH
- •Coronary Artery Disease (CAD) Subjects:
- •Subject has a Positive (+) Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing;
Arms & Interventions
CardioPET
Intervention: CardioPET
Outcomes
Primary Outcomes
Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment.
Time Frame: Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events).
Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.
Secondary Outcomes
- Performance characteristics of CardioPET as a PET tracer for myocardial imaging.(0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min.)
- Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data(Baseline, 15 second time frames for first 2 minutes, 1 min. time frame for next 8 min., 2 min frames for remainder of 60 min study.)