Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03486327
• Other study ID #: BR55-110
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 19, 2018
• Est. completion date: March 31, 2024

Study information

• Verified date: August 2023
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 enrolled into 3 dose groups, 0.03, 0.05, and 0.08 mL/kg, with a maximum of 8 patients in each dose group.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: March 31, 2024
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ßHCG) 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).

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

Drug:
• BR55
A novel targeted ultrasound contrast agent

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Visual assessment of enhancement	BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).	1 Day
Primary	2. Adverse Events	Number of participants who received the contrast agent and experienced an adverse event.	2 Days