Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
Study Details
Study Description
Brief Summary
This phase II trial studies how well perflutren protein-type A microspheres and contrast-enhanced ultrasound work in improving response to radioembolization therapy in patients with liver cancer. Ultrasound contrast agents, such as perflutren protein-type A microspheres, use gas microbubbles to improve image quality. Using contrast-enhanced ultrasound imaging will "pop" these microbubbles and cause tumors to become more sensitive to radiation therapies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVE:
- Characterize the ability of localized ultrasound contrast agent destruction to improve hepatocellular carcinoma (HCC) response to yttrium Y-90 (Y90) radioembolization.
SECONDARY OBJECTIVE:
- Determine if contrast-enhanced ultrasound estimated tumor perfusion can reliably predict HCC response to radioembolization 1-14 days post treatment.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive perflutren protein-type A microspheres intravenously (IV) over 10 minutes and undergo contrast-enhanced ultrasound (CEUS) over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.
GROUP II: Patients undergo standard of care yttrium Y-90 radioembolization.
After completion of study treatment, patients are followed up at 1 month and at 3-4 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group I (perflutren protein-type A microspheres, CEUS) Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization. |
Procedure: Yttrium-90 Microsphere Radioembolization
Undergo standard of care Y-90 radioembolization
Other Names:
Drug: Perflutren Protein-Type A Microspheres
Given IV.
Other Names:
Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo CEUS
|
| Active Comparator: Group II (standard of care) Patients undergo standard of care yttrium Y-90 radioembolization. |
Procedure: Yttrium-90 Microsphere Radioembolization
Undergo standard of care Y-90 radioembolization
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Treatment response to yttrium Y-90 radioembolization [Up to 4 months]
Measured using the modified Response Evaluation Criteria in Solid Tumors. Will be tested with a non-parametric Mann- Whitney U-test of the difference in response distributions between control (radioembolization alone) and experimental group (ultrasound-triggered microbubble destruction [UTMD] + radioembolization). The outcome variable in this analysis, the modified Response Evaluation Criteria in Solid Tumors (mRECIST) score, is treated as an ordinal variable in this analysis.
- Tumor perfusion measured by contrast-enhanced ultrasound between ultrasound-triggered microbubble destruction pulses [Up to 14 days]
Perfusion will be characterized in terms of contrast replenishment time intensity curves fit with a 2-parameter exponential recovery curve. The relationship between the normalized perfusion values from this image processing and the patients' subsequent mRECIST scores in the UTMD + radioembolization group will be evaluated with Spearman's rank order correlation.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be scheduled for sub-lobar radioembolization therapy of a previously untreated HCC mass < 6 cm visible on grayscale ultrasound
-
Be medically stable
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If a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam
-
Have signed informed consent to participate in the study
Exclusion Criteria:
-
Females who are pregnant or nursing
-
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:
-
Patients on life support or in a critical care unit
-
Patients with unstable occlusive disease (e.g., crescendo angina)
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Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
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Patients with uncontrolled congestive heart failure (New York heart Association [NYHA] class IV)
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Patients with recent cerebral hemorrhage
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Patients with known sensitivities to albumin, blood, or blood products
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Patients with known hypersensitivity to perflutren
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Patients with known cardiac shunts
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Patients with known congenital heart defects
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Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary embolism
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Patients with respiratory distress syndrome
-
Patients with a history of bleeding disorders
-
Patients with bilirubin levels > 2 mg/dL
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: John Eisenbrey, PhD, Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17F.222