Enhanced Screening for Liver Cancer
Recruiting in Palo Alto (17 mi)
Overseen byGeorge Ioannou, MD, MS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Washington
Disqualifiers: HCC, Organ transplant, Pregnancy, others
No Placebo Group
Prior Safety Data
Trial Summary
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.
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.
12345Is 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.
15678How 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.
12469Eligibility Criteria
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 am between 18 and 75 years old.
I have cirrhosis or a chronic hepatitis B infection.
+1 more
Exclusion Criteria
I have received an organ transplant.
Participation in another HCC screening trial
CTP score >=10
+8 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Active Control
Group I: aMRI + AFPActive Control1 Intervention
Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months
Group II: Ultrasound + AFPActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cherokee Nation Health ServiceTahlequah, OK
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
National Cancer Institute (NCI)Collaborator
Cherokee Nation Health ServicesCollaborator
Alaska Native Tribal Health ConsortiumCollaborator
References
Eliciting Patient Preferences for Hepatocellular Carcinoma Screening: A Choice-Based Conjoint Analysis. [2022]Abbreviated MRI (AMRI), proposed as an alternative imaging modality for hepatocellular carcinoma screening, provides higher sensitivity than ultrasound. It is, however, unknown how patients weigh the higher sensitivity of AMRI against its higher cost and potentially less desirable testing experience.
The application of abbreviated MRI protocols in malignant liver lesions surveillance. [2023]Cancer is one of the leading public health problems globally. Since time is of the essence in oncology, the sooner an accurate diagnosis is made, the better the prognosis for patients. There is a growing need to find a flawless and fast imaging method for cancer detection, but also for its evaluation during treatment. In this respect, the possibilities and novelties of magnetic resonance imaging are particularly promising. Abbreviated magnetic resonance imaging (AMRI) protocols have aroused universal interest as a compromise between scanning time reduction and preservation of image quality. Shorter protocols focused on the detection of suspicious lesions with the most sensitive sequences could provide a diagnostic performance similar to the one of the standard protocol. The purpose of this article is to review the ongoing accomplishments in the use of AMRI protocols in liver metastases and HCC detection.
Diagnostic Performance of Simulated Abbreviated MRI for Early-Stage Hepatocellular Carcinoma Screening: A Comparison to Conventional Dynamic Contrast-Enhanced MRI. [2022]To compare the per-patient diagnostic performance of simulated abbreviated MRI (AMRI) to that of conventional MRI (CMRI) with full-sequence dynamic gadoxetic acid (GA) enhancement for early-stage hepatocellular carcinoma (HCC) screening in high-risk patients.
Alternative approach of hepatocellular carcinoma surveillance: abbreviated MRI. [2021]This review focuses on emerging abbreviated magnetic resonance imaging (AMRI) surveillance of patients with chronic liver disease for hepatocellular carcinoma (HCC). This surveillance strategy has been proposed as a high-sensitivity alternative to ultrasound for identification of patients with early-stage HCC, particularly in patients with cirrhosis or obesity, in whom sonographic visualization of small tumors may be compromised. Three general AMRI approaches have been developed and studied in the literature - non-contrast AMRI, dynamic contrast-enhanced AMRI, and hepatobiliary phase contrast-enhanced AMRI - each comprising a small number of selected sequences specifically tailored for HCC detection. The rationale, general technique, advantages and disadvantages, and diagnostic performance of each AMRI approach is explained. Additionally, current gaps in knowledge and future directions are discussed. Based on emerging evidence, we cautiously recommend the use of AMRI for HCC surveillance in situations where ultrasound is compromised.
Gadoxetate-enhanced abbreviated MRI is highly accurate for hepatocellular carcinoma screening. [2021]The primary objective was to compare the performance of 3 different abbreviated MRI (AMRI) sets extracted from a complete gadoxetate-enhanced MRI obtained for hepatocellular carcinoma (HCC) screening. Secondary objective was to perform a preliminary cost-effectiveness analysis, comparing each AMRI set to published ultrasound performance for HCC screening in the USA.
Abbreviated MRI for hepatocellular carcinoma screening: A systematic review and meta-analysis. [2022]Biannual ultrasound has poor sensitivity for hepatocellular carcinoma (HCC) screening. MRI is accurate for the detection of HCC, but a complete MRI is not feasible as a screening tool. Abbreviated MRI (AMRI) is an acceptable alternative. The diagnostic performance of different AMRI protocols is not known. We performed a systematic review to determine the diagnostic accuracy of AMRI for HCC screening.
Comparison of noncontrast, dynamic, and hepatobiliary phase abbreviated MRI protocols for detection of hepatic malignancies. [2023]Abbreviated MRI for surveillance in patients at risk for hepatocellular carcinoma (HCC) has recently gained interest.
Abbreviated MRI for HCC surveillance: is it ready for clinical use? [2021]• Abbreviated MRI (AMRI) protocols consist of acquiring only a minimal number of MRI sequences for HCC surveillance with acceptable diagnostic performance compared to complete MRI.• AMRI protocol options include non-contrast AMRI, dynamic AMRI or hepatobiliary phase AMRI post gadoxetate injection.• The best AMRI protocol for HCC surveillance needs to be defined in a large multicentre prospective study.
Abbreviated Liver Magnetic Resonance Imaging Protocols and Applications. [2022]Abbreviated magnetic resonance imaging (AMRI) approach became a hot topic in liver imaging recently. Different AMRI protocols including noncontrast AMRI (NC-AMRI), hepatobiliary-AMRI (HBP-AMRI) using gadoxetic acid, and dynamic-AMRI (Dyn-AMRI) using extracellular contrast agent, have been described in the literature. In this review, the use of these AMRI approaches in various indications including hepatocellular carcinoma (HCC) screening and surveillance in chronic liver disease; fat, iron, and fibrosis screening and assessment in nonalcoholic fatty liver disease (NAFLD); and finally liver metastasis screening and surveillance in patients with colorectal cancer are summarized.