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?

We are performing a pilot and feasibility randomized controlled trial (RCT) of HCC screening by US + AFP every 6 months (n=100), the current standard-of-care, versus aMRI + AFP every 6 months (n=100) for 12 months (i.e. at time 0, 6 and 12 months) among AI/AN patients with cirrhosis or HBV.

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 abbreviated MRI (AMRI) safe for humans?

The research does not provide specific safety data for abbreviated MRI (AMRI), but it is generally considered an acceptable alternative to complete MRI for liver cancer screening. ^{1 2 3 4 5}

How does the treatment Abbreviated MRI differ from other treatments for liver cancer screening?

Abbreviated MRI (AMRI) is unique because it offers higher sensitivity for detecting liver cancer compared to traditional ultrasound, especially in patients with conditions like cirrhosis or obesity where ultrasound may not be as effective. It uses a shorter imaging protocol that balances quick scanning with high-quality images, making it a promising alternative for early cancer detection. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Abbreviated MRI for liver cancer screening?

Research shows that Abbreviated MRI (AMRI) is more sensitive than ultrasound for detecting early-stage liver cancer, especially in patients with conditions like cirrhosis or obesity where ultrasound may not work as well. AMRI is recommended when ultrasound is less effective, and it offers a good balance between quick scanning and maintaining image quality. ^{1 3 6 7 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]

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) 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]

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]

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]

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]

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]

Citations

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

Eliciting Patient Preferences for Hepatocellular Carcinoma Screening: A Choice-Based Conjoint Analysis. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

The application of abbreviated MRI protocols in malignant liver lesions surveillance. [2023]

3. Korea (South) 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. [2022]

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

Alternative approach of hepatocellular carcinoma surveillance: abbreviated MRI. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Gadoxetate-enhanced abbreviated MRI is highly accurate for hepatocellular carcinoma screening. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Abbreviated MRI for hepatocellular carcinoma screening: A systematic review and meta-analysis. [2022]

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

Comparison of noncontrast, dynamic, and hepatobiliary phase abbreviated MRI protocols for detection of hepatic malignancies. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Abbreviated MRI for HCC surveillance: is it ready for clinical use? [2021]

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

Abbreviated Liver Magnetic Resonance Imaging Protocols and Applications. [2022]