Using contrast-enhanced ultrasound to check Y-90 radioembolization response in liver cancer
Contrast-Enhanced Ultrasound Evaluation of Radioembolization Treatment Response
This will test whether contrast-enhanced ultrasound (CEUS) can show treatment response to Y‑90 radioembolization in people with newly diagnosed hepatocellular carcinoma who are scheduled for TARE.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07145801 on ClinicalTrials.gov |
What this trial studies
This prospective Phase 2 study enrolls 30 patients with treatment‑naïve hepatocellular carcinoma visible on ultrasound who are scheduled to receive Y‑90 transarterial radioembolization (TARE). Baseline ultrasound and dual CEUS exams will be performed using Lumason followed by Sonazoid with timed imaging of arterial, late vascular, and Kupffer phases, and data exported for offline analysis. Imaging findings will be compared to the clinical course and routine post‑TARE imaging follow‑up to determine whether CEUS detects viable tumor earlier than standard CT/MRI criteria. Participants will be followed for at least six months after TARE to capture treatment response and any need for retreatment or transplant listing.
Who should consider this trial
Good fit: Adults (≥18 years) with treatment‑naïve HCC visible on ultrasound who are medically stable, scheduled for TARE, and able to consent (with a negative pregnancy test if applicable).
Not a fit: Patients who are medically unstable, seriously or terminally ill, have tumors not visible on ultrasound, or have known sensitivities to Lumason or Sonazoid are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, CEUS could detect viable tumor earlier after TARE, enabling faster retreatment decisions and earlier transplant consideration.
How similar studies have performed: Prior CEUS work in HCC has shown promise for characterizing tumor vascularity and response, but using dual‑contrast CEUS specifically for early post‑TARE response is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled for TARE therapy of a treatment naïve HCC visible on ultrasound. * Be at least 18 years of age. * Be medically stable. * If a female of child-bearing age, must have a negative pregnancy test. * Have signed Informed Consent to participate in the study. Exclusion Criteria: * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. * Patients with known sensitivities to the components of Lumason. * Patients with known sensitivities to the components of Sonazoid.
Where this trial is running
Philadelphia, Pennsylvania
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: John Eisenbrey, PhD — Thomas Jefferson University
- Study coordinator: John Eisenbrey, PhD
- Email: John.Eisenbrey@jefferson.edu
- Phone: (215) 503-5188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.