NCT04528758已完成1 期
Preliminary Evaluation of F-18 Rhodamine 6G in Healthy Individuals and Patients With Stable Heart Condition
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Dosimetry group
研究概览
简要总结
Use of novel radio-pharmaceutical Rhodamine 6G to determine myocardial blood flow
详细描述
Using Rhodamine 6G to determine myocardial blood flow in normal volunteers and patients with coronary heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: 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
干预措施: Rhodamine 6G (Drug)
结局指标
主要结局
Dosimetry group
时间窗: 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
次要结局
- Stable Heart Patients(1-2 days)
研究者
研究点 (1)
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