Status:
TERMINATED
Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions
Lead Sponsor:
Bracco Diagnostics, Inc
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 wi...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03486327
Start Date
July 19 2018
End Date
July 31 2021
Last Update
August 23 2024
Active Locations (1)
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1
Stanford University Medical Center
Palo Alto, California, United States, 94304