Status:
SUSPENDED
F-18 Rhodamine 6G PET Imaging for Myocardial Blood Flow
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Boston Children's Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
21-75 years
Phase:
EARLY_PHASE1
Brief Summary
Use of novel radio-pharmaceutical Rhodamine 6G to determine myocardial blood flow
Detailed Description
Using Rhodamine 6G to determine myocardial blood flow in normal volunteers and patients with coronary heart disease.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04528758
Start Date
October 16 2018
End Date
December 1 2024
Last Update
August 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110