Status:
COMPLETED
A Phase I Study in Healthy Volunteers to Evaluate the Safety of CardioPET™ in Detection of Coronary Artery Disease
Lead Sponsor:
Fluoropharma, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
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...
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 Visi...
Eligibility Criteria
Inclusion
- 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
- 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;
- Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
- Coronary artery bypass graft (CABG) within 1 year;
- Percutaneous coronary intervention (PCI), with stent placement within three months;
- Blood pressure over 180/100;
- Acute changes in ECG;
- Cardiac ischemia identified by MPI stress test;
- Recent (within 3 months) cardiac arrest, unstable angina, myocardial infarction, cerebro-vascular accident (CVA), any general anesthesia procedure, any surgical procedures;
- Any implanted pacemaker or defibrillator use within the last three months;
- Inability to remain in camera for approximately 60 minutes (Smokers and COPD are included as long as they can breath in PET camera and not taking O2 through nasal canola);
- History of Diabetes Mellitus;
- Serum creatinine \> 2 mg/dL;
- All cancer and or chemotherapy patients;
- Body Mass Index (BMI) is over 35;
- Any exposure to any investigational drugs or medical device within four (4) weeks prior to imaging study;
- Any exposure to radiopharmaceuticals within four (4) weeks prior to the date of imaging study;
- High daily alcohol consumption over 4 alcohol drinks per day.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00413647
Start Date
September 1 2006
End Date
February 1 2008
Last Update
June 12 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114