A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET
Completed · Phase 1
Conditions studied: Coronary Artery Disease
In brief
Safety and dosimetry of BFPET™ will be evaluated in healthy volunteers and Coronary Artery Disease (CAD) patients , male or female and of age ranging between 20-80 years old.
Key facts
- Study ID
- NCT00733460
- Run by
- Fluoropharma, Inc.
- People needed
- 12
- Starts
- 2008-03-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2013-06-10
Who can join
Age: 20 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects must provide written informed consent prior to any study related procedures;
- Subjects must be ≥ 20 and ≤ 80 years of age;
- Subjects must have history of CAD documented by an abnormal stress myocardial perfusion imaging (MPI) study and cardiac catheterization within 6 months of the BFPET studyExclusion Criteria
- Exclusion Criteria:
- 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 6 months;
- Percutaneous coronary intervention (PCI), with stent placement within six months;
- Blood pressure over 180/100;
- Acute changes in ECG;
- 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 canula);
- History of Diabetes Mellitus;
- Serum creatinine > 2 mg/dL;
- All cancer 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;
You may not qualify if…
- 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;
- Any exposure to any investigational drugs within four (4) weeks prior to Visit 1;
- Any exposure to investigational 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 Pregnancy Test, or the possibility of pregnancy cannot be ruled out prior to dosing or is breast-feeding. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH.
- Subject has experienced any allergic reaction to similar radiofluorinated compounds or agents.
- CORONARY ARTERY DISEASE (CAD) SUBJECTS
- Inclusion Criteria:
- Subjects must provide written informed consent prior to any study related procedures;
- Subjects must be ≥ 20 and ≤ 80 years of age;
- Subjects must have history of CAD documented by an abnormal stress myocardial perfusion imaging (MPI) study and cardiac catheterization within 6 months of the BFPET studyExclusion Criteria
- Exclusion Criteria:
- 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 6 months;
- Percutaneous coronary intervention (PCI), with stent placement within six months;
- Blood pressure over 180/100;
- Acute changes in ECG;
- 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 canula);
- History of Diabetes Mellitus;
- Serum creatinine > 2 mg/dL;
- All cancer patients;
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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