Phase-I Study of Radiolabeled DFH-12 (PulmoBind) for Molecular Imaging of the Pulmonary Circulation

Inclusion criteria

• 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

Exclusion criteria

• 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-12. Includes but not limited to:

• lung parenchymal or lung vascular diseases such as chronic obstructive pulmonary disease,
• bronchitis,
• lung cancer,
• pleural effusion,
• emphysema,
• asthma,
• pulmonary fibrosis,
• occupational lung disease,
• pulmonary hypertension (primary or secondary),
• systemic hypertension,
• diabetes,
• cancer,
• 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)