Y-90 Treatment Response Using Transarterial Radioembolization

Summary

This prospective clinical study will examine the ability of contrast-enhanced ultrasound (CEUS) to assess the treatment response of hepatocellular carcinoma (HCC) to transarterial radioembolization (TARE). HCC is the third leading cause of cancer mortality worldwide and the single fastest growing cause of cancer mortality in the United States. TARE is recommended for 15-25% of HCC patients. Treatment response is generally evaluated using contrast-enhanced Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) 1-2 months and 4-6 months post-TARE. Although TARE is an effective therapy, assessment of treatment response using CT/MRI is challenging because CT/MRI frequently diagnoses tumor response as equivocal or non-progressing for up to 6 months post-TARE based on Liver Imaging Reporting and Data System (LI-RADS) criteria. This delay in diagnosing tumor viability subsequently delays needed retreatment and can even serve as a barrier to transplantation. Our prior work in HCC locoregional therapy has shown CEUS provides improved sensitivity in detecting viable tumor following transarterial chemoembolization relative to traditional CT/MRI. Therefore, the investigators propose to evaluate both qualitative and quantitative CEUS as a tool for evaluating HCC post-TARE at similar time points of clinically recommended cross-sectional imaging, while also investigating the role of Kupffer phase imaging.

The investigator plans to enroll a total of 30 patients scheduled for TARE of a treatment naïve HCC over an 18-month period, allowing for a minimum of 6 months follow up. Patients will undergo a CEUS examination within two weeks of their first two clinically indicated CT/MRI exams (obtained at Jefferson 1-2 months and 4-6 months post TARE). Patients will be recruited across six major hospitals within the Jefferson Health Enterprise. Those eligible for participation will be identified by project co-investigators and contacted by the study coordinator to discuss participation and to explain the study. The patient will be given time to consider the risks and benefits of the study and ask questions about participation. If agreeable, the patient will then arrange with the project coordinator to come to Jefferson's center city campus to sign consent and take part in the research study.

Conditions

• HCC
• Hepatocellular Carcinoma
• Liver Cancer
• Hepatic Neoplasm
• Primary Liver Cancer
• Liver Neoplasm

Interventions

DIAGNOSTIC_TEST

Lumason

Following baseline ultrasound imaging, CEUS will be performed using dual B-mode and CEUS mode. For the first injection using Lumason the approximate tumor mid-line will be imaged during breath hold until complete tumor enhancement is achieved followed by imaging sweeps through the tumor. Intermittent imaging will be performed after that. Following a 10 minute Lumason wash-out period, participants will then receive a bolus injection of Sonazoid with identical imaging protocol to Lumason for the first 60 seconds to evaluate arterial phase enhancement. Imaging sweeps of the tumor will then be obtained at 1 and 2 minutes to evaluate enhancement within the late vascular phase to detect early washout. After visualization in the late phase, imaging will resume to evaluate the Kupffer phase of contrast enhancement. Following completion of the exam, patients will be monitored for at least 30 minutes before being discharged and all data will be exported for later off-line analysis

DIAGNOSTIC_TEST

Sonazoid

Participants will receive a bolus injection up to (0.12 µl of MB/kg) of Sonazoid, followed by 5-10 ml of normal saline. Imaging of Sonazoid will be identical to the protocol described above for the first 60 seconds to evaluate arterial phase enhancement. Imaging sweeps (5-10 seconds) of the tumor will then be obtained in at 1 and 2 minutes to evaluate enhancement within the late vascular phase and detect early washout. After that imaging will resume to evaluate the Kupffer phase of contrast enhancement. Kupffer phase imaging (also called the postvascular phase) starts approximately 8-10 mins after injection when the free circulating microbubbles have been eliminated from the vasculature with Kupfer-cell enhancement persisting for up to 2 hours. Sonazoid CEUS will be performed in all patients after Lumason clearance from the circulation, usually within 15 min after injection.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Thomas Jefferson University

  lead OTHER

Principal Investigators

• John Eisenbrey, PhD · Thomas Jefferson University

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-11

Primary Completion

2027-06-30

Completion

2027-06-30

FDA Drug

Yes

Countries

• United States

Study Locations