Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/6/2019 |
| Start Date: | July 1, 2017 |
| End Date: | January 1, 2020 |
| Contact: | John Eisenbrey, PhD |
| Email: | john.eisenbrey@jefferson.edu |
| Phone: | (215) 503-5188 |
Ultrasound Microbubble Destruction and Perfusion Quantification for Improving Radioembolization Therapy of Hepatocellular Carcinoma
This randomized pilot clinical 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.
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.
PRIMARY OBJECTIVES:
I. Characterize the ability of localized ultrasound contrast agent destruction to improve
hepatocellular carcinoma (HCC) response to yttrium Y-90 (Y90) radioembolization.
II. Determine if contrast-enhanced ultrasound estimated tumor perfusion can reliably predict
HCC response to radioembolization 1-14 days post treatment.
I. Characterize the ability of localized ultrasound contrast agent destruction to improve
hepatocellular carcinoma (HCC) response to yttrium Y-90 (Y90) radioembolization.
II. Determine if contrast-enhanced ultrasound estimated tumor perfusion can reliably predict
HCC response to radioembolization 1-14 days post treatment.
Inclusion Criteria:
- Be scheduled for sub-lobar radioembolization therapy of a previously untreated HCC
mass < 6 cm visible on grayscale ultrasound
- Be medically stable
- 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)
- Patients with clinically unstable cardiac arrhythmias, such as recurrent
ventricular tachycardia
- Patients with uncontrolled congestive heart failure (New York heart Association
[NYHA] class IV)
- Patients with recent cerebral hemorrhage
- Patients with known sensitivities to albumin, blood, or blood products
- Patients with known hypersensitivity to perflutren
- Patients with known cardiac shunts
- Patients with known congenital heart defects
- Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
- Patients with respiratory distress syndrome
- Patients with a history of bleeding disorders
- Patients with bilirubin levels > 2 mg/dL
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