F-18 Rhodamine 6G PET Imaging for Myocardial Blood Flow

This is an interventional diagnostic trial for Coronary Artery Disease Read More

Inclusion Criteria:

• Male and female, 21-75 years of age and any race.
• Capable of giving written informed consent.
• "Healthy adult volunteer subject" is someone who is volunteering to undergo imaging procedures and based on screening procedures has no known significant health problems.
• Stable patients with known or suspected coronary artery disease that are scheduled to have or have undergone a clinically indicated conventional rest/stress SPECT MPI and no intervention between SPECT and PET.
• Female subjects must not be pregnant or lactating.

Exclusion Criteria:

• Has any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the subject, limit the subject's ability to tolerate the research procedures, or interfere with collection of the data.
• Have abnormal findings on any screening/baseline procedure, e.g. physical examination, laboratory tests, electrocardiogram that suggest the subject might have a condition that could, in the opinion of the Sponsor-Investigator, affect the subject's response to the radiopharmaceutical or related research procedures.
• Is deemed likely to be unable to perform all research procedures for any reason, (e.g., subjects unable to lie still or inability to tolerate up to 60 minutes in a supine position with arms up during the PET imaging procedures due to chronic back/shoulder pain or arthritis as assessed by physical examination and medical history).
• Has a history of hypersensitivity to Fluorine-18 or other radiopharmaceutical or any of its excipients.
• Have contraindications to cardiovascular PET/CT imaging such as claustrophobia.
• Have high blood pressure (>200/110)
• Have Epilepsy
• Have major kidney or liver problems
• Have current or past history of major medical illness
• Currently using recreational drugs
• Body weight of > 300 lbs. (weight limit of the PET/CT table)

• Stable Cardiac Disease: Rest/Stress Group only:

  • Cardiac patients who suffer an intervening clinical event such as worsening angina pectoris or myocardial infarction or whom undergo a myocardial revascularization procedure or have myocardial ischemia at rest.
  • Sinus node disease (e.g. SA block) or symptomatic bradycardia, second or third degree atrioventricular (AV) block.
  • Pre-existing obstructive lung disease (e.g. asthma) that precludes the safe administration of the pharmacological stressor according to the approved label.
  • Uncontrolled and severe hypertension (e.g. systolic blood pressure >200 mmHg, diastolic blood pressure >110 mmHg).
  • Baseline hypotension (e.g. systolic blood pressure < 90 mmHg, diastolic blood pressure <50 mmHg).
  • Seizures
  • The use of caffeine, nicotine or over the counter cold medicines within 12 hours prior to stress imaging day with regadenoson.
  • The theophylline-based medications or dipyridamole within 48 hours prior to each imaging day.