A Phase I Study in Healthy Volunteers to Evaluate the Safety of CardioPET™ in Detection of Coronary Artery Disease

Completed · Phase 1

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00413647

Run by

Fluoropharma, Inc.

People needed

21

Starts

2006-09-01

Expected to finish

2008-02-01

Last updated by the study team

2013-06-12

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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