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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03300401
• Other study ID #: 3L-17-3
• Secondary ID: NCI-2017-014223L
• Status: Withdrawn
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: November 7, 2020

Study information

• Verified date: May 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 7, 2020
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for 90Y radioembolization for HCC as part of their standard of care

Exclusion Criteria:

• Patients who have already received tumor treatment (either systemic or loco-regional such as previous Y90RE, microwave or radiofrequency [RF] ablation or transarterial chemoembolization [TACE])

• Pregnant or nursing

• Known cardiac shunt

• Known pulmonary hypertension

• History of hypersensitivity to Definity (perflutren lipid microsphere) or Lumason

• History of hypersensitivity to iodinated contrast agent

• Cannot consent for himself or herself

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Perflutren Lipid Microspheres
Receive intravenous injection just prior to ultrasound
• Sulfur Hexafluoride Lipid Microspheres
Receive intravenous injection just prior to ultrasound

Device:
• Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo Contrast-Enhanced Ultrasound Imaging
• Positron Emission Tomography
Undergo PET/CT
• Computed Tomography
Undergo CT scan

Biological:
• Yttrium-90 (90Y)
Given IV

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tumor response to therapy	Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.	Up to 24 weeks