NCT03486327

Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	BR55	A novel targeted ultrasound contrast agent

Timeline

• Start date: 2018-07-19
• Primary completion: 2020-11-13
• Completion: 2021-07-31
• First posted: 2018-04-03
• Last updated: 2024-08-23
• Results posted: 2024-08-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study