Y-90 Treatment Response Using Transarterial Radioembolization

NCT07145801 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: 2025-0539JT 454931R21CA303648
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

transarterial radioembolization; TARE; CEUS; contrast-enhanced ultrasound; hepatocellular; carcinoma; HCC; hepatocellular carcinoma (HCC); liver cancer; liver tumors; liver lesions; microbubbles; liver parenchyma; liver imaging; HCC locoregional therapy; Ultrasound; Kupffer; Yttrium-90; tumor viability; time intensity curves; parametric maps; microbubble destruction; bolus contrast injection; CEUS biomarker; Y90 TARE

Outcome Measures

Primary Outcomes (2)

• Tumor viability on contrast enhanced ultrasound using a blood pooling contrast agent

  Viability of tumor assessed by three radiologists using contrast-enhanced ultrasound

  1-2 months post treatment

• Tumor viability on contrast enhanced ultrasound using a blood pooling contrast agent

  Viability of tumor assessed by three radiologists using contrast-enhanced ultrasound

  3-6 months post treatment

Secondary Outcomes (2)

• Tumor viability on contrast enhanced ultrasound using a Kupffer cell-specific contrast agent

  1-2 months post treatment

• Tumor viability on contrast enhanced ultrasound using a Kupffer cell-specific contrast agent

  3-6 months post treatment

Study Arms (1)

CEUS with Lumason and Sonazoid

EXPERIMENTAL

The plan is 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).

Diagnostic Test: Lumason; Diagnostic Test: Sonazoid

Interventions

Lumason DIAGNOSTIC_TEST

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

Also known as: sulfur hexafluoride lipid-type A microspheres, SonoVue, SF6 lipid microspheres, Sulfur hexafluoride lipid microspheres, Sulfur Hexafluoride, SF₆ microspheres

CEUS with Lumason and Sonazoid

Sonazoid DIAGNOSTIC_TEST

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.

Also known as: Perflubutane, Perfluorobutane microbubbles, NC100100 acoustic contrast agent

CEUS with Lumason and Sonazoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• John Eisenbrey, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Eisenbrey, PhD

CONTACT

(215) 503-5188; John.Eisenbrey@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 28, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)