Clinical trial · Interventional
Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
Ultrasound Microbubble Destruction and Perfusion Quantification for Improving Radioembolization Therapy of Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dynamic Contrast-Enhanced Ultrasound Imaging | Procedure | — | UNRESOLVED |
| Perflutren Protein-Type A Microspheres | Drug | — | UNRESOLVED |
| Yttrium-90 Microsphere Radioembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (perflutren protein-type A microspheres, CEUS)
- description
- 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.
- interventionNames
- Procedure: Yttrium-90 Microsphere Radioembolization
- Drug: Perflutren Protein-Type A Microspheres
- Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging
- type
- ACTIVE_COMPARATOR
- label
- Group II (standard of care)
- description
- Patients undergo standard of care yttrium Y-90 radioembolization.
- interventionNames
- Procedure: Yttrium-90 Microsphere Radioembolization
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 embolism * Patients with respiratory distress syndrome * Patients with a history of bleeding disorders * Patients with bilirubin levels \> 2 mg/dL
References
Publications (1)
- DERIVEDWessner CE, Forsberg F, Lyshchik A, O'Kane P, Bradigan K, Liu JB, Delaney LJ, Anton K, Topper SR, Civan J, Maley W, Keith SW, Shaw CM, Eisenbrey JR. Microbubble-based Radiosensitization of Hepatocellular Carcinoma: Evaluation of Safety and Efficacy in a Phase II Randomized Trial. Radiology. 2025 Sep;316(3):e250083. doi: 10.1148/radiol.250083. PMID 41025990