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Not Recruiting
Trial ID: NCT03486327
Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
Professor of Radiology (Body Imaging)
Associate Professor of Medicine (Gastroenterology and Hepatology)
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).
drug: BR55
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mahima Goel
650.723.0371