Transarterial Radioembolization for Liver Cancer

(TARE Trial)

Overseen By John Eisenbrey, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Thomas Jefferson University

Disqualifiers: Medically unstable, Terminally ill, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to evaluate the effectiveness of transarterial radioembolization (TARE) for liver cancer. TARE is commonly used for liver cancer, but regular scans like CT or MRI often struggle to show early results. The trial employs a special ultrasound method, contrast-enhanced ultrasound (CEUS), to determine if it can provide clearer and quicker results. The trial seeks participants scheduled to receive TARE for previously untreated liver cancer, with tumors visible on an ultrasound. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study coordinator or your doctor.

What prior data suggests that contrast-enhanced ultrasound (CEUS) is safe for assessing treatment response in liver cancer?

Research has shown that transarterial radioembolization (TARE) is generally safe for treating liver cancer. Studies have found that TARE is as safe as other treatments and is well-tolerated by patients with liver tumors. For instance, one study found that TARE had similar long-term survival rates and fewer side effects compared to surgery for liver cancer. This indicates it works well without causing more harm than other treatments. Another study confirmed this by demonstrating that TARE effectively controls tumors and maintains a good safety record.

In summary, current research considers TARE safe and it has been used successfully for liver cancer with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transarterial Radioembolization (TARE) is unique because it offers a targeted way to treat liver cancer by delivering radiation directly to the tumor through the blood vessels. Unlike traditional treatments like surgery or systemic chemotherapy, which can affect the entire body, TARE focuses the radiation on the liver tumor itself, potentially reducing side effects and sparing healthy tissue. Researchers are excited about TARE because it combines the precision of localized treatment with the power of radiation therapy, which could improve outcomes for patients with liver cancer.

What evidence suggests that contrast-enhanced ultrasound is effective for assessing liver cancer treatment response?

Research has shown that transarterial radioembolization (TARE) effectively treats liver cancer, known as hepatocellular carcinoma (HCC), regardless of tumor size. Studies have found that TARE offers survival rates comparable to other treatments for HCC patients. Additionally, TARE is as safe as other treatment options. In some cases, TARE serves as the first treatment choice and has demonstrated promising results in managing liver cancer. This evidence supports TARE as a reliable treatment option for HCC patients. Participants in this trial will undergo a CEUS examination with Lumason and Sonazoid to evaluate TARE's effectiveness. ^{2 3 5 6 7}

Who Is on the Research Team?

John Eisenbrey, PhD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for adults with a type of liver cancer called hepatocellular carcinoma (HCC) who haven't had treatment yet and can be seen on ultrasound. Women able to have children must test negative for pregnancy, all participants need to consent to the study, and they should be medically stable.

Inclusion Criteria

Be medically stable

Have signed Informed Consent to participate in the study

I am of child-bearing age and my pregnancy test is negative.

Exclusion Criteria

Patients with known sensitivities to the components of Lumason

Patients who are medically unstable, seriously or terminally ill, or have an unpredictable clinical course

Patients with known sensitivities to the components of Sonazoid

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Baseline ultrasound imaging and B-mode measurements are performed

1 day

1 visit (in-person)

Treatment

Participants undergo transarterial radioembolization (TARE) for hepatocellular carcinoma

1 day

1 visit (in-person)

Post-Treatment Imaging

Contrast-enhanced ultrasound (CEUS) examinations are performed within two weeks of CT/MRI exams at 1-2 months and 4-6 months post-TARE

6 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Transarterial Radioembolization

Trial Overview The study tests how well contrast-enhanced ultrasound (CEUS) checks the response of HCC to a treatment called transarterial radioembolization (TARE). It compares CEUS results with standard CT/MRI scans at 1-2 months and 4-6 months after TARE in patients across six hospitals.

How Is the Trial Designed?

Group I: CEUS with Lumason and Sonazoid Experimental Treatment 2 Interventions

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).

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12249255/

Transarterial Chemoembolization Outperforms ... The study concluded that TACE was found to provide better survival outcomes, especially for patients with early-stage liver cancer, and had ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e16333

Comparative outcomes of transarterial radioembolization in ... TARE demonstrates comparable survival and adverse outcomes in HCC patients, irrespective of tumor size, supporting its efficacy and safety.

3. jnm.snmjournals.org jnm.snmjournals.org/content/63/8/1215

Long-Term Outcomes of Transarterial Radioembolization for ... This study aimed to compare long-term outcomes of transarterial radioembolization (TARE) with resection for patients with large HCC.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1098301516337652

Real-World Data for the Evaluation of Transarterial ... Real-World Data for the Evaluation of Transarterial Radioembolization versus Sorafenib in Hepatocellular Carcinoma: A Cost-Effectiveness Analysis. Author ...

5. frontiersin.org frontiersin.org/journals/radiology/articles/10.3389/fradi.2024.1346550/full

Outcome of transarterial radioembolization in patients with ... The aim of the study is to compare the results of transarterial radioembolization (TARE) as the first-line therapy and as a subsequent therapy following prior ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468452/

Safety of Combination TARE and SBRT in Hepatocellular ... Our study demonstrates that treatment with TARE and SBRT was safe and effective among our small sample of patients. 1. Introduction. Liver ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2589555922002051

Factors impacting survival after transarterial ... Several studies have shown that TARE has a favourable safety profile and displays promising results in terms of local tumour control in patients with ...