NCT03300401

Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization

The Role of Quantitative Contrast-Enhanced Ultrasound in Yttrium-90 (90Y) Radioembolization of Hepatocellular Carcinoma

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies how well contrast-enhanced ultrasound in diagnosing patients with liver cancer who are undergoing Yttrium-90 radioembolization. Contrast-enhanced ultrasound may provide detailed imaging of the tumor arteries after the injection of a contrast-agent consisting of microbubbles, and may predict how much Yttrium-90 will deposit in the tumor.

Detailed description

PRIMARY OBJECTIVES: I. Investigate the relationship between hepatocellular carcinoma (HCC) tumor perfusion on pre-procedural contrast-enhanced ultrasound (CEUS) time intensity curve (TIC) and post-procedural Yttrium-90 (90Y) microsphere distribution after 90Y radioembolization (RE). SECONDARY OBJECTIVES: I. Study the potential of serial CEUS TIC examinations as a marker of tumor treatment response as assessed at 20 - 24 week computed tomography (CT) follow-up. OUTLINE: Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo positron emission tomography/computed tomography (PET/CT) after standard of care 90Y radioembolization at baseline.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Perflutren Lipid Microspheres	Receive intravenous injection just prior to ultrasound
DRUG	Sulfur Hexafluoride Lipid Microspheres	Receive intravenous injection just prior to ultrasound
DEVICE	Dynamic Contrast-Enhanced Ultrasound Imaging	Undergo Contrast-Enhanced Ultrasound Imaging
DEVICE	Positron Emission Tomography	Undergo PET/CT
DEVICE	Computed Tomography	Undergo CT scan
BIOLOGICAL	Yttrium-90 (90Y)	Given IV

Timeline

• Start date: 2017-11-07
• Primary completion: 2019-11-07
• Completion: 2020-11-07
• First posted: 2017-10-03
• Last updated: 2019-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study