Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Registration Number
- NCT03486327
- Lead Sponsor
- Bracco Diagnostics, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria:<br><br>Enroll a subject in this study if the subject meets the following inclusion criteria:<br><br> - Is at least 18 years of age;<br><br> - Has at least one solid pancreatic lesion;<br><br> - Is scheduled to undergo surgical resection for suspected PDAC not earlier than 24<br> hours and not later than 30 days following BR55 administration;<br><br> - Provides written Informed Consent and is willing to comply with protocol<br> requirements.<br><br>Exclusion Criteria:<br><br>Exclude a subject from this study if the subject does not fulfill the inclusion criteria,<br>or if any of the following conditions are observed:<br><br> - Is a pregnant or lactating female. Exclude the possibility of pregnancy:<br><br> - by testing on site at the institution (serum ßHCG) within 24 hours prior to the<br> start of investigational product (IP) administration,<br><br> - by surgical history (e.g., tubal ligation or hysterectomy),<br><br> - by post-menopausal status with a minimum 1 year without menses;<br><br> - Has undergone prior systemic therapy for pancreatic cancer;<br><br> - Has history of any concurrent malignancy;<br><br> - Has history of any clinically unstable cardiac condition including class III/IV<br> congestive heart failure;<br><br> - Has had any severe cardiac rhythm disorders within 7 days prior to enrolment;<br><br> - Has severe pulmonary hypertension (pulmonary artery pressure > 90mmHg) or<br> uncontrolled systemic hypertension and/or respiratory distress syndrome;<br><br> - Has open and/or non-healing wounds in the chest, abdomen and pelvis;<br><br> - Has other systemic vascular abnormalities associated with neovascularization, such<br> as macular degeneration, that in the opinion of the investigator could significantly<br> affect the ability to evaluate the effects of BR55;<br><br> - Is participating in a clinical trial or has participated in another trial with an<br> investigational compound within the past 30 days prior to enrolment;<br><br> - Has previously been enrolled in and completed this study;<br><br> - Has any known allergy to one or more of the ingredients of the IP or to any other<br> contrast media;<br><br> - Is determined by the Investigator that the subject is clinically unsuitable for the<br> study;<br><br> - Has had major surgery, including laparoscopic surgery within 3 months prior to<br> enrolment;<br><br> - Has history of pancreatic surgery (e.g., cyst removal);<br><br> - Has acute pancreatic abnormalities (acute pancreatitis or trauma).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Visual Assessment of Enhancement;2. Adverse Events
- Secondary Outcome Measures
Name Time Method