Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

Inclusion Criteria

• Inclusion Criteria: Enroll a subject in this study if the subject meets the following 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. Exclusion Criteria: Exclude a subject from this study if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed: - 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).