The Role of Quantitative Contrast-Enhanced Ultrasound in Yttrium-90 (90Y) Radioembolization of Hepatocellular Carcinoma
Overview
- Phase
- N/A
- Intervention
- Perflutren Lipid Microspheres
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- University of Southern California
- Locations
- 1
- Primary Endpoint
- Local tumor response to therapy
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Diagnostic (CEUS)
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.
Intervention: Perflutren Lipid Microspheres
Diagnostic (CEUS)
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.
Intervention: Sulfur Hexafluoride Lipid Microspheres
Diagnostic (CEUS)
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.
Intervention: Dynamic Contrast-Enhanced Ultrasound Imaging
Diagnostic (CEUS)
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.
Intervention: Positron Emission Tomography
Diagnostic (CEUS)
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.
Intervention: Computed Tomography
Diagnostic (CEUS)
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.
Intervention: Yttrium-90 (90Y)
Outcomes
Primary Outcomes
Local tumor response to therapy
Time Frame: Up to 24 weeks
Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.