Screening Methods for Liver Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy

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

Compensation: Varies

Number of Visits: 3

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial studies the use of surveys, blood testing, and fibroscan in screening for liver fibrosis and liver cirrhosis in new or existing patients of the HOPE clinic seeking usual clinical care. Fibroscan is an imaging procedure of the liver which uses a probe like an ultrasound. Information gathered from this study may help researchers learn more about how to prevent or find liver cancer in patients who are currently receiving care at the HOPE clinic. Early detection of liver cancer may improve survival.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is the liver cancer screening method safe for humans?

The use of ultrasound enhancement agents in liver cancer screening is generally safe, with very rare reports of serious adverse reactions. The safety profile of these agents is similar to or better than other imaging methods that use contrast agents. ^{1 2 3 4 5}

How does the treatment Liver Ultrasonographic Elastography differ from other treatments for liver cancer?

Liver Ultrasonographic Elastography is unique because it is a non-invasive imaging technique that measures liver stiffness to assess liver fibrosis, unlike traditional methods that often require a liver biopsy. This approach allows for quick, repeatable assessments and helps in managing liver disease without the need for invasive procedures. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment for liver cancer?

Ultrasound elastography, a part of the treatment, is effective in assessing liver stiffness and differentiating between benign and malignant tumors, which can help in managing liver diseases and potentially improve liver cancer screening. ^{6 10 11 12 13}

Who Is on the Research Team?

Jessica P. Hwang

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can speak and read English or another language with available translation at the HOPE clinic. It's open to new or current patients seeking regular care at the clinic, but pregnant individuals cannot participate.

Inclusion Criteria

Must be able to speak and read English or a language other than English for which there is a translator available on site at the HOPE clinic

Must be a new or existing patient of the HOPE clinic seeking usual clinical care

Exclusion Criteria

Known pregnancy at time of recruitment. The HOPE clinic will ask the female patients if they are pregnant, will ask the participants for their last menstrual period (LMP), and/or they will use the urine pregnancy test (UPT) results in their electronic medical records

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete surveys, undergo blood testing, clinical evaluation, and fibroscan

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after baseline assessment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Evaluation
• Laboratory Biomarker Analysis
• Liver Ultrasonographic Elastography
• Survey Administration

Trial Overview The study is testing how well surveys, blood tests, and a liver scan called Fibroscan can screen for liver fibrosis and cirrhosis in patients. The goal is to find better ways to detect liver cancer early on in people getting care at the HOPE clinic.

How Is the Trial Designed?

Group I: Screening (survey, biomarker analysis, fibroscan) Experimental Treatment 4 Interventions

Patients complete surveys over 10-15 minutes, and undergo blood testing, clinical evaluation, and fibroscan at baseline.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Cancer Prevention Research Institute of Texas

Collaborator

Trials

55

Recruited

98,900+

Published Research Related to This Trial

Ultrasound elastography is a noninvasive imaging technique that estimates tissue elasticity, which can help differentiate and characterize various malignant tumors, including those in the breast, prostate, and liver.

This technique has been particularly effective in assessing liver fibrosis in patients with diffuse liver diseases, indicating its potential to enhance ultrasound diagnostics in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time sonoelastography - a new application in the field of liver disease. Gheorghe, L., Iacob, S., Gheorghe, C.[2016]

In a review of over 201,000 administrations of ultrasound enhancement agents (UEAs), severe and critical adverse drug reactions (ADRs) were found to be more frequent with Lumason compared to Definity, with rates of 0.0848% for severe and 0.0330% for critical ADRs associated with Lumason.

The frequency of severe ADRs with Lumason has increased in recent years, and patients experiencing these reactions were more likely to have received a COVID-19 vaccination, particularly the Moderna vaccine, suggesting a potential link that requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of Severe Adverse Drug Reactions to Ultrasound Enhancement Agents in a Contemporary Echocardiography Practice. Ali, MT., Johnson, M., Irwin, T., et al.[2023]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

The role of ultrasound elastographic techniques in chronic liver disease: current status and future perspectives. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of Multimodal Sound Touch Elastography for Differentiating Benign and Malignant Breast Masses. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Real-time elastography--an advanced method of ultrasound: First results in 108 patients with breast lesions. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Intrasurgical dignity assessment of hepatic tumors using semi-quantitative strain elastography and contrast-enhanced ultrasound for optimisation of liver tumor surgery. [2018]

5. Romania pubmed.ncbi.nlm.nih.gov

Real-time sonoelastography - a new application in the field of liver disease. [2016]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Can Risk Stratification Based on Ultrasound Elastography of Background Liver Assist CEUS LI-RADS in the Diagnosis of HCC? [2022]

7. England pubmed.ncbi.nlm.nih.gov

Association between ultrasound quality and test performance for HCC surveillance in patients with cirrhosis: a retrospective cohort study. [2022]

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

Dynamic Changes in Ultrasound Quality for Hepatocellular Carcinoma Screening in Patients With Cirrhosis. [2023]

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

Incidence of Severe Adverse Drug Reactions to Ultrasound Enhancement Agents in a Contemporary Echocardiography Practice. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Adverse effects associated with SonoVue use. [2022]

11. Czech Republic pubmed.ncbi.nlm.nih.gov

Noninvasive diagnostics of liver diseases - imaging methods. [2020]

12. Czech Republic pubmed.ncbi.nlm.nih.gov

Liver elastography. [2022]

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

Ultrasound elastographic techniques in focal liver lesions. [2018]