Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

Inclusion Criteria

• •Is at least 18 years of age;
• •Has at least one solid pancreatic lesion;
• •Is scheduled to undergo surgical resection for suspected PDAC not earlier than 24 hours and not later than 30 days following BR55 administration;
• •Provides written Informed Consent and is willing to comply with protocol requirements.
• •Is a pregnant or lactating female. Exclude the possibility of pregnancy:
• •* by testing on site at the institution (serum βHCG) within 24 hours prior to the start of investigational product (IP) administration,
• •* by surgical history (e.g., tubal ligation or hysterectomy),
• •* by post-menopausal status with a minimum 1 year without menses;
• •Has undergone prior systemic therapy for pancreatic cancer;
• •Has history of any concurrent malignancy;
• •Has history of any clinically unstable cardiac condition including class III/IV congestive heart failure;
• •Has had any severe cardiac rhythm disorders within 7 days prior to enrolment;
• •Has severe pulmonary hypertension (pulmonary artery pressure \> 90mmHg) or uncontrolled systemic hypertension and/or respiratory distress syndrome;
• •Has open and/or non-healing wounds in the chest, abdomen and pelvis;
• •Has other systemic vascular abnormalities associated with neovascularization, such as macular degeneration, that in the opinion of the investigator could significantly affect the ability to evaluate the effects of BR55;
• •Is participating in a clinical trial or has participated in another trial with an investigational compound within the past 30 days prior to enrolment;
• •Has previously been enrolled in and completed this study;
• •Has any known allergy to one or more of the ingredients of the IP or to any other contrast media;
• •Is determined by the Investigator that the subject is clinically unsuitable for the study;
• •Has had major surgery, including laparoscopic surgery within 3 months prior to enrolment;
• •Has history of pancreatic surgery (e.g., cyst removal);
• •Has acute pancreatic abnormalities (acute pancreatitis or trauma).