Phase-I Study of Radiolabeled DFH-12 (PulmoBind) for Molecular Imaging of the Pulmonary Circulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To determine optimal dose of PulmoBind to be administered for lung imaging in humans
研究概览
简要总结
Pulmonary hypertension (PH) can be the result of various clinical conditions. It may be idiopathic or associated with various cardiovascular and lung disorders. Currently there is no test that can non-invasively detect abnormalities of the pulmonary circulation. There is a growing need for a non-invasive method to detect PH. There currently exists only ne agent approved in Canada for clinical imaging of the pulmonary circulation, 99mTc-labeled macroaggregates. This agent is exclusively used for the diagnosis of physical defects of the circulation due to pulmonary embolus. This agent is larger than small pulmonary vessels, limiting its sensitivity to detect small vascular defects, as well as potential infectious risks since albumin macroaggregates are derived from human albumin. There is need then for new lung tracers that could provide a greater safety profile while enabling functional as well as anatomical imaging of the pulmonary circulation. DFH-12 (PulmoBind) is a peptide derived from human adrenomedullin (hAMI-52). Hence the development of this novel AM derivative, PulmoBind, for molecular imaging of the pulmonary circulation. PulmoBind is labeled with 99mTc, the most commonly used imaging isotope in nuclear medicine.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female greater than 18 years of age. Female subjects must be post-menopausal (defined as two years after menstrual cycle)
- •within normal range for the following: BP systolic 100-140 mmHg and diastolic 50-90 mmHg;
- •HR 60-100 beats per minute;
- •oral temperature less than 37.6 degrees Centigrade;
- •respiratory rate 12-20 breaths per minute;
- •normal lung function tests;
- •normal echocardiogram including estimation of pulmonary artery systolic pressure;
- •normal chest x-ray; Normal electrocardiogram
排除标准
- •any known chronic or acute medical condition with or without the need for chronic pharmacologic therapy or any condition that may interfere with normal biodistribution of DFH-
- •Includes but not limited to:
- •lung parenchymal or lung vascular diseases such as chronic obstructive pulmonary disease,
- •bronchitis,
- •lung cancer,
- •pleural effusion,
- •emphysema,
- •pulmonary fibrosis,
- •occupational lung disease,
- •pulmonary hypertension (primary or secondary),
- •systemic hypertension,
- •diabetes,
- •kidney disease,
- •liver disease,
- •heart failure or previous myocardial infarction,
- •coronary artery disease,
- •peripheral vascular disease or inflammatory disease;
- •subjects requiring chronic administration of any substance for a medical condition, active smoking or history of smoking for more than one year in the past 10 years, known self-reported alcoholism (active or abstinent);
- •unable to tolerate study procedures ex.(venipuncture, movement restrictions during imaging);
- •previous nuclear study since one week (to avoid cross-contamination)
结局指标
主要结局
To determine optimal dose of PulmoBind to be administered for lung imaging in humans
时间窗: 48 hours
To determine the optimal dose of Pulmobind by evaluating the safety and efficacy in three groups of subjects with 3 different doses of study drug; 5mCi, 10mCi, and 15 mCi.For safety evaluation we will provide pharmacokinetic and biodistribution data following injections of the 3 doses mentioned. Vital signs, hematology and biochemistry will also be captured for each of the doses up to 24 and 48 hours after injections of PulmoBind. Furthermore local and systemic reactions 24 hours and 48 hours after injections of PulmoBind will also be captured.
次要结局
未报告次要终点