Recruiting
Phase 2

CEUS

Sponsor:

Thomas Jefferson University

Code:

NCT07145801

Conditions

HCC

Hepatocellular Carcinoma

Liver Cancer

Hepatic Neoplasm

Primary Liver Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lumason

Sonazoid

Study Details

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 CT or 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 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 investigators plan 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). In patients retreated prior to their 4-6 month MRI, CEUS may also be performed in the absence of the MRI at this time point but prior to retreatment. 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

Study ID

NCT07145801

Start date

Sep 11, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: CEUS with Lumason and Sonazoid

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). If retreatment is elected prior to the 4-6 month time point, CEUS can be performed within 1-2 weeks of retreatment and angiography (obtained during retreatment) used as the reference standard.

Interventions

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

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.

Primary outcome measure

  • Tumor viability on contrast enhanced ultrasound using a blood pooling contrast agent [ Time Frame: 1-2 months post treatment ]
  • Tumor viability on contrast enhanced ultrasound using a blood pooling contrast agent [ Time Frame: 3-6 months post treatment ]

Central Contacts and Locations

Central contacts

Locations

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

More Information

Sponsor

Thomas Jefferson University

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-06-10.