Enhanced Screening for Liver Cancer

Overseen By Stephanie Y Park

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Washington

Disqualifiers: HCC, Organ transplant, Pregnancy, 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: 3

Duration: 12 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to screen for liver cancer in individuals with liver damage or chronic hepatitis B. One group will undergo an ultrasound and blood test every six months, while the other group will receive a shorter MRI (Abbreviated MRI) and the same blood test on the same schedule. It targets those with cirrhosis (a type of liver damage) or chronic hepatitis B who are at high risk for liver cancer. Participants should not have a prior diagnosis of liver cancer or be currently suspected of having it. As a Phase 2 trial, this research focuses on measuring the effectiveness of the screening methods in an initial, smaller group of people.

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

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both abbreviated MRI (aMRI) and ultrasound are safe methods for liver cancer screening. Although studies do not provide detailed safety data for aMRI, it is generally considered safe and is gaining popularity for effectively detecting early signs of liver cancer.

Ultrasound is a well-established and widely used method for liver cancer screening, with a strong safety record. Some studies have noted that it might be less effective in certain conditions, such as cirrhosis, but it remains a safe and common choice for many patients.

Both aMRI and ultrasound offer advantages and disadvantages, but safety concerns are minimal, making them reliable options for liver cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Enhanced Screening for Liver Cancer trial because it explores two innovative methods that could improve early detection. The abbreviated MRI (aMRI) offers a quicker and potentially more detailed scan of the liver compared to traditional ultrasound, which is the current standard for liver cancer screening. This could lead to earlier and more accurate detection of liver abnormalities. Additionally, both aMRI and ultrasound screenings include serum AFP testing, a blood test that can help identify liver cancer markers. By comparing these methods, researchers aim to determine the most effective screening approach, potentially improving outcomes for patients.

What evidence suggests that this trial's treatments could be effective for liver cancer screening?

Research has shown that the abbreviated MRI (aMRI), which participants in this trial may receive, effectively detects early-stage liver cancer, known as hepatocellular carcinoma (HCC). This means aMRI can accurately identify cancer when present and avoid false positives when it is not. Studies have found that aMRI surpasses ultrasound in detecting small liver tumors. However, ultrasound, another screening method tested in this trial, remains a reliable and widely used method for liver cancer screening. It has effectively identified various types of HCC, improving survival chances when cancer is caught early. Both aMRI and ultrasound are used to assess liver health, especially in individuals with conditions like cirrhosis or chronic hepatitis B. ^{2 6 7 8 9}

Who Is on the Research Team?

George Ioannou, MD, MS

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for American Indian and Alaska Native individuals aged 18-75 with liver cirrhosis or chronic Hepatitis B, who are at high risk of developing liver cancer. They must be able to give informed consent. Those with a prior diagnosis of liver cancer, severe liver dysfunction, kidney issues, contraindication to MRI, or pregnancy cannot participate.

Inclusion Criteria

I am at high risk for liver cancer.

I have cirrhosis or a chronic hepatitis B infection.

I understand and can agree to the study's procedures and risks.

Exclusion Criteria

I have received an organ transplant.

Participation in another HCC screening trial

CTP score >=10

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo HCC screening by US + AFP or aMRI + AFP every 6 months for 12 months

12 months

3 visits (in-person) at 0, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abbreviated MRI
• Ultrasound

Trial Overview The study compares two methods of screening for liver cancer: ultrasound plus Alpha-Fetoprotein (AFP) testing versus abbreviated MRI plus AFP testing every six months over a year in patients at high risk for hepatocellular carcinoma.

How Is the Trial Designed?

Group I: aMRI + AFP Active Control 1 Intervention

Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months

Group II: Ultrasound + AFP Active Control 1 Intervention

Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months

Abbreviated MRI is already approved in United States, European Union for the following indications:

Approved in United States as Abbreviated MRI for:

• Hepatocellular carcinoma screening

Approved in European Union as Abbreviated MRI for:

• Hepatocellular carcinoma screening

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Cherokee Nation Health Services

Collaborator

Trials

2

Recruited

340+

Alaska Native Tribal Health Consortium

Collaborator

Trials

20

Recruited

9,600+

Published Research Related to This Trial

Patients prioritize higher sensitivity in screening tests for hepatocellular carcinoma, with an importance score of 39.8%, indicating that they value the ability to accurately detect cancer over other factors.

Cost and lower false-positive rates are also significant considerations for patients, with scores of 22.8% and 19.4% respectively, suggesting that affordability and test reliability are crucial for patient adherence to screening recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eliciting Patient Preferences for Hepatocellular Carcinoma Screening: A Choice-Based Conjoint Analysis. Fazeli, S., Covarrubias, Y., Bassirian, S., et al.[2022]

Abbreviated magnetic resonance imaging (AMRI) protocols are gaining attention for their ability to reduce scanning time while maintaining high image quality, which is crucial for timely cancer diagnosis.

AMRI shows promise in detecting liver metastases and hepatocellular carcinoma (HCC), potentially offering diagnostic performance comparable to standard MRI protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of abbreviated MRI protocols in malignant liver lesions surveillance. Winder, M., Grabowska, S., Hitnarowicz, A., et al.[2023]

Abbreviated magnetic resonance imaging (AMRI) is emerging as a high-sensitivity alternative to ultrasound for monitoring patients with chronic liver disease for early-stage hepatocellular carcinoma (HCC), especially in those with cirrhosis or obesity where ultrasound may not be effective.

Three AMRI techniques—non-contrast, dynamic contrast-enhanced, and hepatobiliary phase contrast-enhanced—have been developed, each tailored for HCC detection, and the review suggests cautiously recommending AMRI when ultrasound is inadequate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternative approach of hepatocellular carcinoma surveillance: abbreviated MRI. Brunsing, RL., Fowler, KJ., Yokoo, T., et al.[2021]

Non-contrast abbreviated MRI (NC-AMRI) has limited sensitivity for detecting hepatocellular carcinoma (HCC) at 61.5%, while dynamic AMRI (Dyn-AMRI) and hepatobiliary phase AMRI (HBP-AMRI) show significantly higher sensitivities of 84.6% and 80.8%, respectively.

All abbreviated MRI methods demonstrated high specificity and were found to be cost-effective compared to ultrasound for HCC screening, providing a life-year gain of 3-12 months at incremental costs of less than $12,000.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadoxetate-enhanced abbreviated MRI is highly accurate for hepatocellular carcinoma screening. Vietti Violi, N., Lewis, S., Liao, J., et al.[2021]

HBP-aMRI demonstrated the highest sensitivity (94.6%) for detecting hepatic malignancies in patients at risk for hepatocellular carcinoma, outperforming both Dyn-aMRI and NC-aMRI.

Dyn-aMRI had the best specificity (91.7%) compared to HBP-aMRI and NC-aMRI, indicating it is more reliable in correctly identifying non-malignant lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of noncontrast, dynamic, and hepatobiliary phase abbreviated MRI protocols for detection of hepatic malignancies. Lee, JH., Kim, YK., Min, JH., et al.[2023]

In a study of 201 high-risk patients for hepatocellular carcinoma (HCC), simulated abbreviated MRI (AMRI) demonstrated a per-patient sensitivity of 94.9% and a negative predictive value (NPV) of 96.4%, which is comparable to conventional MRI (CMRI) with sensitivity of 96.2% and NPV of 97.5%.

The inter-reader agreement for both AMRI and CMRI was almost perfect, indicating that AMRI, which uses only three imaging sequences, could serve as an effective alternative screening tool for early-stage HCC in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of Simulated Abbreviated MRI for Early-Stage Hepatocellular Carcinoma Screening: A Comparison to Conventional Dynamic Contrast-Enhanced MRI. Lim, ES., Kim, SM., Shin, SS., et al.[2022]

Abbreviated magnetic resonance imaging (AMRI) has emerged as a promising technique for liver imaging, with various protocols like noncontrast AMRI, hepatobiliary-AMRI, and dynamic-AMRI being utilized for different liver conditions.

AMRI is effective for screening and monitoring liver diseases, including hepatocellular carcinoma, nonalcoholic fatty liver disease, and liver metastases in colorectal cancer patients, highlighting its versatility in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abbreviated Liver Magnetic Resonance Imaging Protocols and Applications. Altinmakas, E., Taouli, B.[2022]

Abbreviated MRI (AMRI) demonstrated high sensitivity (86%) and specificity (94%) for screening hepatocellular carcinoma (HCC) in a systematic review of 15 studies involving 2,807 patients, making it a promising alternative to traditional ultrasound.

While AMRI is effective for detecting larger HCC tumors (≥2 cm), its sensitivity drops for smaller tumors (<2 cm), but it still outperforms ultrasound, which had a sensitivity of only 53%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abbreviated MRI for hepatocellular carcinoma screening: A systematic review and meta-analysis. Gupta, P., Soundararajan, R., Patel, A., et al.[2022]

Abbreviated MRI (AMRI) protocols can effectively monitor hepatocellular carcinoma (HCC) with fewer sequences than traditional MRI, maintaining acceptable diagnostic performance.

Different AMRI options, such as non-contrast, dynamic, or hepatobiliary phase after gadoxetate injection, are available, but further research in a large multicenter study is needed to determine the optimal protocol for HCC surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abbreviated MRI for HCC surveillance: is it ready for clinical use? Vietti Violi, N., Taouli, B.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33548385/

Abbreviated MRI for hepatocellular carcinoma screening Our study results showed that AMRI has a high per-patient and per-lesion sensitivity for HCC. Although the sensitivity of AMRI for detection of ...

2. journal-of-hepatology.eu journal-of-hepatology.eu/article/S0168-8278(21)00091-X/abstract

Abbreviated MRI for hepatocellular carcinoma screening Our study results showed that AMRI has a high per-patient and per-lesion sensitivity for HCC. Although the sensitivity of AMRI for detection of HCC <2 cm is ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589555925000333

Multicenter evaluation of abbreviated MRI and ultrasound ... We found that AMRI had significantly higher per-patient sensitivity and specificity compared with ultrasound for the detection of early-stage HCC.

4. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/rg.2020200104

Abbreviated MRI for Hepatocellular Carcinoma Screening ... Abbreviated MRI shows promise as a screening study for hepatocellular carcinoma (HCC) surveillance in adults with cirrhosis or chronic hepatitis B virus ...

5. academicradiology.org academicradiology.org/article/S1076-6332(24)00993-0/abstract

Value of Abbreviated Magnetic Resonance Sequence in ... To systematically review the diagnostic efficacy of abbreviated magnetic resonance imaging sequence (AMRI) screening for hepatocellular carcinoma (HCC).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11312001/

Prospective Study of Non-Contrast, Abbreviated MRI for ... Experts evaluated the aMRI scans and felt they were of good quality. Our study shows that aMRI is possible and useful in patients undergoing ...

7. journal-of-hepatology.eu journal-of-hepatology.eu/article/S0168-8278(24)00334-9/fulltext

Improving HCC surveillance with abbreviated MRI: A call to ... Multiple published studies have reported promising per-patient results with AMRI, but they should be interpreted with caution. Indeed, most were ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7714535/

Abbreviated MRI for Hepatocellular Carcinoma Screening ... Studies have shown that the per-patient sensitivity of US for small HCCs (<2 cm), defined as Barcelona Clinic Liver Cancer stage 0 or A, is as low as 47%–63% (5 ...

9. withpower.com withpower.com/trial/phase-2-liver-cirrhosis-3-2022-5d603?condition=Liver+Cancer&overallStatus=Recruiting&hasNoPlacebo=true

Enhanced Screening for Liver Cancer Is abbreviated MRI (AMRI) safe for humans? The research does not provide specific safety data for abbreviated MRI (AMRI), but it is generally considered an ...