Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

NCT03486327 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: BR55-110
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 1. Visual Assessment of Enhancement

  BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).

  Up to 24 hours post-dose on Day 1

• 2. Adverse Events

  Number of participants who received the contrast agent and experienced an adverse event.

  From the time of signing Informed Consent through 24 hours post-dose, up to a maximum of 11 days

Study Arms (3)

0.03mL/kg Dose Group

EXPERIMENTAL

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

Drug: BR55

0.05mL/kg Dose Group

EXPERIMENTAL

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

Drug: BR55

0.08mL/kg Dose Group

EXPERIMENTAL

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

Drug: BR55

Interventions

BR55 DRUG

A novel targeted ultrasound contrast agent

0.03mL/kg Dose Group; 0.05mL/kg Dose Group; 0.08mL/kg Dose Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Results Point of Contact

• Title: Giordana Marioni, Clinical Trial Assistant
• Organization: Bracco Diagnostics Inc.

giordana.marioni@diag.bracco.com

609-514-2282

Study Officials

• Maria Luigia Storto, MD

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to 24 subjects will be enrolled into 3 dose groups starting with the lowest dose group as follows: Dose group 0.03mL/kg, dose group 0.05mL/kg and dose group 0.08mL/kg/, with a maximum of 8 patients in each dose group.

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: April 3, 2018
• Study Start: July 19, 2018
• Primary Completion: November 13, 2020
• Study Completion: July 31, 2021
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)