Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: BR55

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

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.03mL/kg Dose Group; A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.	Drug: BR55; A novel targeted ultrasound contrast agent
Experimental: 0.05mL/kg Dose Group; A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.	Drug: BR55; A novel targeted ultrasound contrast agent
Experimental: 0.08mL/kg Dose Group; A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.	Drug: BR55; A novel targeted ultrasound contrast agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
2. Adverse Events	Number of participants who received the contrast agent and experienced an adverse event.	2 Days

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc
• Collaborators: National Institutes of Health (NIH)
• Investigators: Study Director: Maria Luigia Storto, MD, Bracco Diagnostics, Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): October 31, 2021
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: BR55-110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No