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

The Washington University

Status and phase

Suspended

Early Phase 1

Conditions

Coronary Artery Disease

Treatments

Drug: Rhodamine 6G

Study type

Interventional

Funder types

Other

Identifiers

NCT04528758

201808025

Details and patient eligibility

About

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

Full description

Using Rhodamine 6G to determine myocardial blood flow in normal volunteers and patients with coronary heart disease.

Enrollment

15 estimated patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.