Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Organ Dosimetry
研究概览
简要总结
This study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68Ga-Galmydar for PET/CT imaging.
详细描述
The objective is to evaluate dosimetry, biodistribution, safety, and imaging characteristics following a single 68Ga-Galmydar injection in normal healthy volunteers. Healthy adult normal volunteers (n=8, 4 males; 4 females) will undergo whole-body imaging (dosimetry group).
Healthy adult normal volunteers (n=8, 4 males; 4 females) will receive a single intravenous Ga-68 Galmydar administration of 8 mCi ± 20% (6.4-9.6 mCi) with a mass of ≤ 10 µg followed by whole-body PET/CT imaging.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women, 18-99 years of age and any race
排除标准
- •Inability to receive and sign informed consent;
- •Positive urine screen for drugs of abuse at screening or before dosing or over-the- counter drug use or herbal preparations within the 2-week period prior to enrollment;
- •Participation in another research study with a study drug, including a diagnostic or therapeutic radiopharmaceutical, to be administered during this study or which was or will be administered within 10 hall-lives of the radiopharmaceutical.
- •Severe claustrophobia;
- •Pregnant or breastfeeding.
- •Body mass index < 18 kg/m2 or > 40 kg/m2.
研究组 & 干预措施
Dosimetry Group
Normal Volunteers will receive a single intravenous injection of 8 mCi ± 20% (6.4-9.6 mCi) of the PET radiotracer 68Ga-Galmydar. They will undergo whole-body PET/CT imaging at three-time points, immediately post [68Ga]Galmydar injection, and at 2 hours and 4 hours after injection. Serum chemistries, complete blood count, EKG, vital signs, and physical examination will performed before injection and at the completion of the examinations.
干预措施: Ga-68 Galmydar (Drug)
结局指标
主要结局
Organ Dosimetry
时间窗: 6 hours from 68Ga-Galmydar injection
On whole body PET/CT, regions of interest are drawn on the liver, spleen, kidney, lumbar vertebrae and left ventricle of the heart. Average organ dose is measured and compared. Organ radiation dose is measured and reported in rad/mCi.
Biodistribution
时间窗: 6 hours from 68Ga-Galmydar injection
The organ with the highest radiation dose in rad/mCi is determined to be the dose-critical organ. The organ showing the largest dose is the gallbladder wall.
Total Effective Dose of the Radiotracer
时间窗: 6 hours from 68Ga-Galmydar injection
Total Effective Dose of the radiotracer is calculated using ICRP-60 organ weights and is reported in rem/mCi.
次要结局
- Clinically Significant Change in Respiratory Rate.(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Elevation in Oral Temperature(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in White Blood Cell Count (WBC)(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in Mean Corpuscular Volume (MCV)(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in Platelets(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in EKG Showing New AV Block(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in Red Blood Cell Count (RBC)(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in Hematocrit (Hct)(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in Blood Pressure.(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in Heart Rate.(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in EKG Showing New Bradycardia(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST(6 hours from 68Ga-Galmydar injection)
- Clinically Significant Change in Hemoglobin (Hgb)(6 hours from 68Ga-Galmydar injection)
研究者
Pamela Woodard, MD
H M Wilson Professor of Radiology
Washington University School of Medicine