Sponsor decision; expiration of available study agent due to long recruitment timeline.

This is an exploratory, single center, open label, parallel-dose, and prospective study of BR55 contrast-enhanced ultrasonography (CEUS) for characterization of solid pancreatic lesions in subjects with suspected pancreatic ductal adenocarcinoma (PDAC) using transabdominal US.

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 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).

As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.

Safety monitoring began at the time of signing Informed Consent and continued for 24 hours after BR55 administration, up to a maximum of 11 days.

As of July 31, 2021, enrollment was terminated for Study BR55-110 due to expiration of available BR55. Therefore, only 4 participants were enrolled in the first cohort of this study (0.03 mL/kg). No participant was enrolled in the 0.05 mL/kg or 0.08 mL/kg groups.