Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
Trial ID or NCT#
NCT03486327
Status
NOT RECRUITING
Purpose
This is an exploratory, single center, open label, parallel-dose, and prospective study of BR55 CEUS for characterization of solid pancreatic lesions in subjects with suspected PDAC using transabdominal US.
Official Title
Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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).
Investigator(s)
Walter Park
Gastroenterologist,
Pancreas specialist,
Gastrointestinal specialist,
Pancreatologist
Associate Professor of Medicine (Gastroenterology and Hepatology)
Contact us to find out if this trial is right for you.
Contact
Mahima Goel
650.723.0371
View on ClinicalTrials.gov
