NCT04528758CompletedPhase 1
Preliminary Evaluation of F-18 Rhodamine 6G in Healthy Individuals and Patients With Stable Heart Condition
Washington University School of Medicine1 site in 1 country15 target enrollmentStarted: October 16, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Dosimetry group
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
- •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.
Arms & Interventions
Dosimetry group
Experimental
Patients in the dosimetry group will be imaged with the radio-pharmaceutical Rhodamine 6G at different time points. 0-120, 30-150, 60-180
Intervention: Rhodamine 6G (Drug)
Stable Heart Patients
Active Comparator
Stable heart patients will be given a rest/stress PET/CT with Rhodamine 6G myocardial perfusion study to determine myocardial blood flow
Intervention: Rhodamine 6G (Drug)
Outcomes
Primary Outcomes
Dosimetry group
Time Frame: 1-2 days
Evaluate both image quality and myocardial blood flow at different imaging time points. Image quality provides higher count Density and high spatial resolution, which makes it easier to see the heart vessels, and myocardial blood flow is measured in mL/g/min. Both measurements will be agregated to arrive at one reported value helps determine the balance of heart disease and in small and large vessels
Secondary Outcomes
- Stable Heart Patients(1-2 days)
Investigators
Study Sites (1)
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