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

Not Applicable

Withdrawn

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Perflutren Lipid Microspheres; Drug: Sulfur Hexafluoride Lipid Microspheres; Device: Dynamic Contrast-Enhanced Ultrasound Imaging; Device: Positron Emission Tomography; Device: Computed Tomography; Biological: Yttrium-90 (90Y)

• Registration Number: NCT03300401
• Lead Sponsor: University of Southern California

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Study Start: 2017-11-07
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16
• Primary Completion: 2019-11-07
• Study Completion: 2020-11-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (CEUS)	Perflutren Lipid Microspheres	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 PET/CT after standard of care 90Y radioembolization at baseline.
Diagnostic (CEUS)	Sulfur Hexafluoride Lipid Microspheres	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 PET/CT after standard of care 90Y radioembolization at baseline.
Diagnostic (CEUS)	Dynamic Contrast-Enhanced Ultrasound Imaging	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 PET/CT after standard of care 90Y radioembolization at baseline.
Diagnostic (CEUS)	Positron Emission Tomography	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 PET/CT after standard of care 90Y radioembolization at baseline.
Diagnostic (CEUS)	Computed Tomography	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 PET/CT after standard of care 90Y radioembolization at baseline.
Diagnostic (CEUS)	Yttrium-90 (90Y)	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 PET/CT after standard of care 90Y radioembolization at baseline.

Primary Outcome Measures

Name	Time	Method
Local tumor response to therapy	Up to 24 weeks	Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.

Trial Locations

Locations (1)

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States