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

• Status: Suspended
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Use of novel radio-pharmaceutical Rhodamine 6G to determine myocardial blood flow

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Boston Children's Hospital
• Treatments: Rhodamine 6G

Criteria

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.