Contrast-Enhanced Ultrasound for Liver Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: john eisenbrey

Disqualifiers: Medically unstable, Terminally ill, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial evaluates the diagnostic performance of contrast-enhanced ultrasound (CEUS) for assessing treatment response in patients undergoing transarterial chemoembolization (TACE) for liver tumors. TACE is a hepatic artery embolization technique involving the injection of a blocking agent and a chemotherapy agent to treat liver cancers. Currently, contrast enhanced magnetic resonance imaging or computed tomography are used to assess disease response 1-2 months after TACE treatment, but ultrasound may be a less expensive, earlier alternative. CEUS is an imaging procedure that uses high-frequency sound waves to generate images of the body after administering Lumason, an imaging agent used to enhance visualization of blood flow on ultrasounds. CEUS is able to be performed during the TACE procedure, making it possible to evaluate treatment response earlier than standard techniques. CEUS may be an effective method to evaluate treatment response more accurately and much earlier than current standard evaluation methods.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Sulfur Hexafluoride Lipid Microspheres, Lumason, and Transarterial Chemoembolization (TACE) for liver cancer?

Research shows that using contrast-enhanced ultrasound (CEUS) to guide transarterial chemoembolization (TACE) can help evaluate and improve treatment response in patients with liver cancer. This suggests that CEUS, when combined with TACE, may be effective in treating liver cancer.

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Is contrast-enhanced ultrasound for liver cancer safe?

Transarterial chemoembolization (TACE), a related procedure, is generally considered safe but can have complications like liver abscess, liver failure, and acute cholecystitis (inflammation of the gallbladder). These complications are rare but important to be aware of when considering similar treatments.

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How is the treatment Transarterial Chemoembolization (TACE) for liver cancer different from other treatments?

Transarterial Chemoembolization (TACE) is unique because it delivers chemotherapy directly to the liver tumor through the blood vessels, blocking the tumor's blood supply and trapping the drug inside the tumor. This targeted approach can be more effective and less harmful to the rest of the body compared to traditional chemotherapy, which circulates throughout the entire body.

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Eligibility Criteria

This trial is for patients with liver tumors who are undergoing a treatment called transarterial chemoembolization (TACE). Participants should be eligible for TACE and able to undergo contrast-enhanced ultrasound (CEUS) imaging. The study aims to include those who can provide informed consent and have no conditions that would interfere with CEUS.

Inclusion Criteria

Have signed informed consent to participate in the study

Be medically stable

I am scheduled for a specific liver tumor treatment.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Imaging

Participants receive Lumason IV and undergo CEUS 2 weeks prior to TACE

2 weeks

1 visit (in-person)

Treatment

Participants undergo CEUS during TACE procedure

During TACE procedure

1 visit (in-person)

Post-Treatment Imaging

Participants undergo CEUS 1-2 weeks after TACE

1-2 weeks

1 visit (in-person)

Follow-up Imaging

Participants undergo CEUS 1-2 months after TACE

1-2 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Participant Groups

The trial is testing the use of contrast-enhanced ultrasound (CEUS) during TACE procedures in liver tumor patients. It compares CEUS's ability to assess treatment response earlier against standard methods like MRI or CT scans, which are done later.

Group I: Diagnostic (CEUS) Experimental Treatment 4 Interventions

Patients receive lumason IV and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE. Intervention(s)

Transarterial Chemoembolization is already approved in United States, China, European Union for the following indications:

🇺🇸 Approved in United States as TACE for:

• Non-small cell lung cancer
• Lung metastases

🇨🇳 Approved in China as TACE for:

• Unresectable lung cancer
• Advanced lung cancer

🇪🇺 Approved in European Union as TACE for:

• Non-small cell lung cancer
• Lung metastases

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia, PA

Who Is Running the Clinical Trial?

john eisenbrey Lead Sponsor

Thomas Jefferson University Lead Sponsor

References

1. Cyprus pubmed.ncbi.nlm.nih.gov

Efficacy of endostar combined with transcatheter arterial chemoembolization and analysis of vascular endothelial factor and C-reactive protein levels in patients with advanced hepatocellular carcinoma under contrast enhanced ultrasound. [2020] To evaluate the effect of transcatheter arterial chemoembolization (TACE) under the guidance of contrast-enhanced ultrasound (CEUS) in patients with advanced hepatocellular carcinoma (HCC).

2. Cyprus pubmed.ncbi.nlm.nih.gov

Efficacy of endostar combined with transcatheter arterial chemoembolization and analysis of vascular endothelial factor and C-reactive protein levels in patients with advanced hepatocellular carcinoma under contrast enhanced ultrasound. [2020] To evaluate the effect of transcatheter arterial chemoembolization (TACE) under the guidance of contrast-enhanced ultrasound (CEUS) in patients with advanced hepatocellular carcinoma (HCC).

3. Germany pubmed.ncbi.nlm.nih.gov

Comparison of contrast-enhanced ultrasound and contrast-enhanced computed tomography in evaluating the treatment response to transcatheter arterial chemoembolization of hepatocellular carcinoma using modified RECIST. [2020] We aimed to compare contrast-enhanced ultrasound (CEUS) with contrast-enhanced computed tomography (CECT) for evaluating the treatment response to transcatheter arterial chemoembolization (TACE) of hepatocellular carcinoma (HCC).

4. Turkey pubmed.ncbi.nlm.nih.gov

Evaluation of CT vascularization patterns for survival prognosis in patients with hepatocellular carcinoma treated by conventional TACE. [2018] Transarterial chemoembolization (TACE) is an established treatment for intermediate stage hepatocellular carcinoma (HCC). The aim of this retrospective study was to evaluate the power of lesion vascularization criteria based on computed tomography for prognosis of overall survival before initiation of treatment.

5. England pubmed.ncbi.nlm.nih.gov

Utility of Contrast-Enhanced Ultrasound for Early Therapeutic Evaluation of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization. [2020] We aimed to investigate whether contrast-enhanced ultrasound (CEUS) could be useful for early evaluation of the treatment response to transcatheter arterial chemoembolization (TACE) of hepatocellular carcinoma (HCC).

6. Greece pubmed.ncbi.nlm.nih.gov

Complications of image-guided transcatheter hepatic chemoembolization of primary and secondary tumours of the liver. [2010] Image-guided transcatheter hepatic chemoembolization (TACE) is accepted worldwide as an effective treatment for patients with unresectable hepatocellular carcinoma (HCC) and for adequate preservation of liver function. Although considered relatively safe, TACE has been associated with several complications. The aim of this study was to determine the prevalence of the complications associated with TACE therapy and to correlate it with certain risk factors, either well-known or not yet evaluated.

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

An Unusual Complication of Transarterial Chemoembolization of Hepatocellular Carcinoma; Pseudoaneurysm: A Case Report. [2022] Transarterial chemoembolization (TACE) is a globally recognised treatment method for hepatic tumors, especially unresectable hepatocellular carcinoma (HCC). Although the technique is relatively safe, it may cause serious complications, such as liver abscess, liver failure, and non-target embolization. Here, the case of a rare complication of TACE is presented.

8. Spain pubmed.ncbi.nlm.nih.gov

Complications of transarterial chemoembolization (TACE) in the treatment of liver tumors. [2021] Transarterial chemoembolization (TACE) is considered a therapeutic option. It is mostly used in hepatocellular carcinoma or liver colorectal, neuroendocrine or melanoma metastases. Although it is considered a safe procedure, TACE presents complications, such as acute cholecystitis, which is the most common. Other procedure-related complications include pulmonary embolism, hepatic abscess, bile duct injury, gastric mucosa injury and, less frequently, acute pancreatitis. The aim of this study is to review the complications following TACE for liver tumors.

9. England pubmed.ncbi.nlm.nih.gov

Transarterial chemoembolization of hepatocellular carcinoma before liver transplantation and risk of post-transplant vascular complications: a multicentre observational cohort and propensity score-matched analysis. [2021] Transarterial chemoembolization (TACE) in patients with hepatocellular cancer (HCC) on the waiting list for liver transplantation may be associated with an increased risk for hepatic artery complications. The present study aims to assess the risk for, primarily, intraoperative technical hepatic artery problems and, secondarily, postoperative hepatic artery complications encountered in patients who received TACE before liver transplantation.

10. China pubmed.ncbi.nlm.nih.gov

Acute pancreatitis as a complication of trans-arterial chemoembolization of hepatocellular cancer-case report and review of literature. [2020] Transarterial chemoembolization (TACE) is a therapeutic procedure often performed for hepatocellular carcinoma (HCC). Local complications, though generally uncommon, can arise from arterial ischemia and local cytotoxicity from the chemotherapeutic delivery. We present a case of acute pancreatitis as a rare complication of the TACE procedure along with a review of literature of this uncommon adverse effect.

11. United States pubmed.ncbi.nlm.nih.gov

Contrast-Enhanced Ultrasound in Residual Tumor of Hepatocellular Carcinoma following Transarterial Chemoembolization: Is It Helpful for Tumor Response? [2022] To investigate the enhancement pattern of residual tumor on contrast-enhanced ultrasonography (CEUS) in patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE).

12. England pubmed.ncbi.nlm.nih.gov

Comparison of volume perfusion computed tomography and contrast-enhanced ultrasound for assessment of therapeutic effect of transarterial chemoembolization in patients with hepatocellular carcinoma: a preliminary report. [2016] Evaluation of transarterial chemoembolization (TACE) by using contrast-enhanced ultrasound (CEUS) and volume perfusion computed tomography (VPCT) as methods that display tumor vascularization.

13. Korea (South) pubmed.ncbi.nlm.nih.gov

The usefulness of contrast-enhanced ultrasonography in the early detection of hepatocellular carcinoma viability after transarterial chemoembolization: pilot study. [2018] The therapeutic effect of transarterial chemoembolization (TACE) against hepatocellular carcinoma (HCC) is usually assessed using multidetector computed tomography (MDCT). However, dense lipiodol depositions can mask the enhancement of viable HCC tissue in MDCT. Contrast-enhanced ultrasonography (CEUS) could be effective in detecting small areas of viability and patency in vessels. We investigated whether arterial enhancement in CEUS after treatment with TACE can be used to detect HCC viability earlier than when using MDCT.