Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
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- STATUS
- Recruiting
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- End date
- Dec 29, 2023
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- participants needed
- 104
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- sponsor
- Sidney Kimmel Cancer Center at Thomas Jefferson University
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.
Description
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.
Details
| Condition | HEPATOCELLULAR CARCINOMA, Malignant Adenoma, Liver Cancer, Adenocarcinoma, cancer, hepatocellular, HEPATIC NEOPLASM, liver cell carcinoma, cancer, liver, liver cancers, Biliary Tract Cancer, cancer, hepatic |
|---|---|
| Treatment | SPECT imaging, Yttrium-90 Microsphere Radioembolization, Perflutren Protein-Type A Microspheres, Dynamic Contrast-Enhanced Ultrasound Imaging |
| Clinical Study Identifier | NCT03199274 |
| Sponsor | Sidney Kimmel Cancer Center at Thomas Jefferson University |
| Last Modified on | 12 November 2021 |
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