A Phase 1 Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 123I-CMICE-013 Administered Intravenously in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Biodistribution of the 123I-CMICE-013 Within the Lungs
研究概览
简要总结
The need exists for alternatives to 99mTc based perfusion radiotracers for cardiac patient management. An alternative radiotracer, I123-CMICE-013, has been developed at the Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute. Initial testing results in rats and pigs suggest that in addition to being a cyclotron-produced alternative to 99mTc tracers, I-123-CMICE-013 may be a superior tracer for measuring myocardial perfusion.This Phase 1 study will study the safety and tolerability, biodistribution, pharmacokinetics and radiation dosimetry, and distribution and localization of I123-CMICE-013in healthy adult volunteers.
详细描述
Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is an established, cost effective tool for the risk stratification and management of patients suspected or known to have coronary artery disease (CAD)Myocardial perfusion imaging is significantly affected by interruptions in the supply of 99mMo, the parent isotope of 99mTc used for the majority of MPI. An alternative radiotracer, I123-CMICE-013,developed at the Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute, has completed pre-clinical trial testing and is ready for Phase 1 human trials.
This Phase I study will be a single centre, open label study. Subjects will receive 2 doses of study drug. One rest dose and one stress dose will be administered on separate days, one week apart. Subjects will undergo a standard clinical exercise stress protocol for the stress dose. Gamma camera imaging following each administration will be done over 2 days.
Biodistribution, pharmacokinetics, dosimetry and safety variables will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years
- •No significant medical history
- •Normal physical exam
- •BMI ≤ 30 kg/m2
- •No current use of prescription medication
- •No clinically significant abnormalities in baseline laboratory work
- •No clinically significant abnormalities in baseline 12 lead electrocardiogram
- •Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening
排除标准
- •Known hypersensitivity to the investigational drug or any of its components
- •Claustrophobia or inability to lie still in a supine position
- •Unwillingness to provide informed consent
研究组 & 干预措施
123I-CMICE-013
Administration and analysis of alternative MPI radiotracer
干预措施: 123I-CMICE-013 (Drug)
结局指标
主要结局
Biodistribution of the 123I-CMICE-013 Within the Lungs
时间窗: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
SPECT imaging was performed immediately following 123I-CMICE-013 injection, after 90 min, 4 hours, 6 hours and 24 hours. Region of interest was manually drawn on planar images. The total number of counts in the full body region of interest of the initial images was taken to correspond to 100% of the injected dose. The uptake in the organ as a percentage to injected dose was calculated.
Biodistribution of the 123I-CMICE-013 Within the Thyroid
时间窗: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
SPECT imaging was performed immediately following 123I-CMICE-013 injection, after 90 min, 4 hours, 6 hours and 24 hours. Region of interest was manually drawn on planar images. The total number of counts in the full body region of interest of the initial images was taken to correspond to 100% of the injected dose. The uptake in the organ as a percentage to injected dose was calculated.
Biodistribution of the 123I-CMICE-013 Within the Heart Wall
时间窗: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
SPECT imaging was performed at rest and at stress with each SPECT scan performed one week apart. SPECT imaging was performed immediately following 123I-CMICE-013 injection, after 90 min, 4 hours, 6 hours and 24 hours. Region of interest was manually drawn on planar images. The total number of counts in the full body region of interest of the initial images was taken to correspond to 100% of the injected dose. The uptake in the organ as a percentage to injected dose was calculated.
Biodistribution of the 123I-CMICE-013 Within the Bladder
时间窗: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
SPECT imaging was performed immediately following 123I-CMICE-013 injection, after 90 min, 4 hours, 6 hours and 24 hours. Region of interest was manually drawn on planar images. The total number of counts in the full body region of interest of the initial images was taken to correspond to 100% of the injected dose. The uptake in the organ as a percentage to injected dose was calculated.
Biodistribution of the 123I-CMICE-013 Within the Liver
时间窗: From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.
SPECT imaging was performed immediately following 123I-CMICE-013 injection, after 90 min, 4 hours, 6 hours and 24 hours. Region of interest was manually drawn on planar images. The total number of counts in the full body region of interest of the initial images was taken to correspond to 100% of the injected dose. The uptake in the organ as a percentage to injected dose was calculated.
次要结局
- Total Effective Dose of 123I-CMICE-013 for Men(From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.)
- Total Effective Dose of 123I-CMICE-013 for Women(From enrollment to completion of imaging was 24 hours for each scan. Rest and stress scans were performed one week apart.)