Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

NCT ID: NCT03486327

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-19
• Study Completion Date: 2021-07-31

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 with suspected pancreatic ductal adenocarcinoma (PDAC) using transabdominal US.

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

0.03mL/kg Dose Group

A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.

Group Type: EXPERIMENTAL

BR55

Intervention Type: DRUG

A novel targeted ultrasound contrast agent

0.05mL/kg Dose Group

A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.

Group Type: EXPERIMENTAL

BR55

Intervention Type: DRUG

A novel targeted ultrasound contrast agent

0.08mL/kg Dose Group

A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.

Group Type: EXPERIMENTAL

BR55

Intervention Type: DRUG

A novel targeted ultrasound contrast agent

Interventions

BR55

A novel targeted ultrasound contrast agent

Intervention Type: DRUG

Eligibility Criteria

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.

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Luigia Storto, MD

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

Stanford University Medical Center

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BR55-110

Identifier Type: -

Identifier Source: org_study_id