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

University of Southern California

Status: Withdrawn

Conditions: Hepatocellular Carcinoma

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03300401

NCI-2017-01422 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

3L-17-3 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Diagnostic (CEUS)

Experimental group

Description:

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.

Treatment:

Device: Dynamic Contrast-Enhanced Ultrasound Imaging

Device: Computed Tomography

Drug: Perflutren Lipid Microspheres

Biological: Yttrium-90 (90Y)

Device: Positron Emission Tomography

Drug: Sulfur Hexafluoride Lipid Microspheres