Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

Approximately twenty-four (24) subjects with suspected PDAC and scheduled to undergo surgical
resection within 30 days (but not before 24 hours) after the transabdominal BR55 CEUS
examination will be enrolled into 3 dose groups, 0.03, 0.05, and 0.08 mL/kg, with a maximum
of 8 patients in each dose group.

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 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).