Phase 2
N=104
Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03199274 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Treatment Response to Yttrium Y-90 Radioembolization — 2; 17; 17; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Yttrium-90 Microsphere Radioembolization (Procedure); Perflutren Protein-Type A Microspheres (Drug); Dynamic Contrast-Enhanced Ultrasound Imaging (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Response to Yttrium Y-90 Radioembolization |
2; 17; 17; 17; 25; 13 | — |
| PRIMARY Tumor Perfusion Measured by Contrast-enhanced Ultrasound Between Ultrasound-triggered Microbubble Destruction Pulses |
62; 38 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Be scheduled for sub-lobar radioembolization therapy of a previously untreated HCC mass 2 mg/dL
Data sourced from ClinicalTrials.gov (NCT03199274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.