Clareo Health | Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Thomas Jefferson University
With
National Institutes of Health (NIH)
National Cancer Institute (NCI)
PRIMARY OBJECTIVE:
I. Characterize the ability of localized ultrasound contrast agent destruction to improve hepatocellular carcinoma (HCC) response to yttrium Y-90 (Y90) radioembolization.
SECONDARY OBJECTIVE:
I. 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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 embolism
