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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to find better ways to screen for liver problems that could lead to liver cancer. It employs surveys, blood tests, and a fibroscan (a liver imaging test similar to an ultrasound) to detect conditions like liver fibrosis and cirrhosis. The goal is to identify liver issues early, potentially preventing or detecting liver cancer sooner and improving patient outcomes. Current or new patients at the HOPE clinic seeking regular care there might be suitable candidates for this trial. As an unphased trial, this study offers patients the chance to contribute to important research that could lead to earlier detection and better prevention of liver cancer.

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.

What prior data suggests that these screening methods are safe for liver cancer detection?

Research has shown that liver ultrasonographic elastography, such as FibroScan, is safe. Studies have found it to be a noninvasive method for assessing liver health. It uses a special tool, similar to an ultrasound, to measure liver stiffness, which can help identify signs of fibrosis (liver scarring) or cirrhosis (severe liver scarring).

FibroScan is quick, usually taking just 5 to 7 minutes. Importantly, it has not been linked to any side effects, making it easy for patients to tolerate. It is also less expensive than a liver biopsy, another method for checking liver issues. Overall, liver elastography provides a reliable and safe way to monitor liver health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using liver ultrasonographic elastography for screening liver cancer because it offers a non-invasive way to evaluate liver stiffness, which can indicate underlying issues like fibrosis or tumors. Unlike traditional imaging techniques, this method uses sound waves to provide real-time data on the liver's elasticity, potentially catching problems earlier and more accurately. This approach could improve early detection compared to standard imaging and blood tests, offering a quicker and safer option for patients.

What evidence suggests that these screening methods are effective for detecting liver cancer?

Research has shown that liver ultrasonographic elastography, such as FibroScan, effectively predicts the progression of liver scarring (fibrosis) and assesses patient survival without liver-related issues. Studies have found that this method can also predict the risk of liver cancer, particularly in patients treated for hepatitis C. This non-invasive test measures liver stiffness, aiding in the early detection of liver problems. In this trial, participants will undergo liver ultrasonographic elastography as part of the screening process. Early detection and monitoring with elastography may help prevent liver cancer or catch it when treatment is more manageable. This method provides valuable insights for patients at risk of liver disease and cancer. ^{2 3 6 7 8}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4483541/

Liver ultrasound elastography: More than staging the disease It has been shown that liver elastography can predict the progression of liver fibrosis and also the survival (hepatic events - free) of the patients with ...

2. news.med.miami.edu news.med.miami.edu/liver-cancer-elastography/

Non-Invasive Test for Liver Disease Can Predict Liver Cancer New research shows that liver elastography is an effective way to predict the risk of liver cancer for patients treated for hepatitis C.

3. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2020192437

Update to the Society of Radiologists in Ultrasound Liver ... Can Liver Ultrasound Elastography Predict the Risk of Hepatocellular Carcinoma Recurrence After Radiofrequency Ablation? A Systematic Review ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0301562918302849

Liver Ultrasound Elastography: An Update to the World ... Screening for hepatocellular carcinoma and portal hypertension should continue despite decrease liver stiffness in patients with advanced disease (LoE 1b ...

5. mskcc.org mskcc.org/cancer-care/patient-education/understanding-your-fibroscan-results

Understanding Your Liver Elastography (FibroScan®) ... FibroScan is a special ultrasound technology that measures liver stiffness (hardness) and fatty changes in your liver.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9608361/

Liver Fibrosis: Point—Ultrasound Elastography Is a Safe, ... Liver Fibrosis: Point—Ultrasound Elastography Is a Safe, Widely Available, Low-Cost, Noninvasive Biomarker of Liver Fibrosis That Is Suitable for Broad ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3594956/

Fibroscan (Transient Elastography) for the Measurement of ... Also, the test takes only 5—7 minutes to perform, it is significantly less expensive than liver biopsy, and it has not been associated with any side effects.

8. uofmhealth.org uofmhealth.org/our-care/specialties-services/liver-elastography

Liver Elastography Liver elastography involves the use of a surface ultrasound probe that delivers a low frequency pulse or shear wave to a small volume of liver tissue under the ...