Hepatocellular Carcinoma (HCC)NCT04539717
FAST (Focused Abbreviated Screening Technique)-MRI Study
An observational study of Hepatocellular Carcinoma (HCC) and Liver Cirrhosis, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
The purpose of this study is to compare the diagnostic value of a reconstructed abbreviated Magnetic Resonance Imaging (MRI) from a full clinical exam, compared to ultrasound (US) for screening of liver cancer. Blood markers will be evaluated to determine their correlation to imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Liver Cirrhosis
- How many people
- 820 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Aug 2020to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosed liver cirrhosis enrolled in imaging-based screening for HCC.
Who may be able to join
- Liver cirrhosis of any etiology.
- 18 years of age and older.
- Enrolled in screening/surveillance program for HCC.
- Clinically indicated imaging-based screening for HCC.
- Willing and able to complete all study procedures within specified time windows.
- Patient is able to give informed consent for this study.
Who cannot join
- Contra-indications to MRI.
- Age less than 18 years.
- Patients with chronic renal failure or inability to tolerate contrast.
- Inability to undergo MRI due to lack of insurance coverage.
- Prior negative screening exam less than 5 months prior to enrollment.
- Prior hepatic resection.
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- Post liver transplantation.
- Previously treated HCC or other liver neoplasm.
- Any other condition or factor that in judgment of study investigator may interfere with study completion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Abbreviated MRI for HCC Screening in Cirrhotic Patients (FAST-MRI Study)
The purpose of this study is to compare the diagnostic value of a reconstructed abbreviated Magnetic Resonance Imaging (MRI) from a full clinical exam, compared to ultrasound (US) for screening of liver cancer. Blood markers will be evaluated to determine their correlation to imaging. This study will help to determine whether abbreviated MRI is superior to ultrasound for diagnosis of liver cancer.
Read the detailed description
Hepatocellular carcinoma (HCC) is the fastest growing cause of cancer death in the United States and now kills over 30,000 Americans annually. To reduce the morbidity and mortality caused by this aggressive cancer, current practice guidelines recommend semi-annual abdominal ultrasound in adults with cirrhosis, the leading risk factor for HCC, to detect HCC nodules when they are small and treatable. Unfortunately, US has poor sensitivity for early-stage HCC in cirrhosis, failing to detect treatable cancer in over half of affected patients. Alternatives such as computed tomography (CT) or magnetic resonance imaging (MRI) are also not ideal due to ionizing radiation (CT), higher cost (MRI), or long exam time (~30-45 min for MRI). An optimal and fast HCC screening method is urgently needed and should be more sensitive and cost-effective than US and avoid ionizing radiation.
This is a prospective cross-sectional single arm non randomized multicenter study enrolling in 4 American centers as follows: Icahn School of Medicine at Mount Sinai-ISMMS, University of California San Diego-UCSD, University of Wisconsin-UW, and Duke University. The composite reference standard will incorporate the clinical results of the full baseline MRI exam and of subsequent imaging and pathology data collected over the next 6 months. Routine clinical follow-up imaging at 6 months will be observed. Patients will then be classified as positive for HCC, negative for HCC, or excluded.
- Conditions
- Hepatocellular Carcinoma (HCC), Liver Cirrhosis
- Keywords
- Magnetic Resonance Imaging (MRI), Ultrasound (US), Liver Diseases, Elastography
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis, Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of HCC
The presence of HCC will be determined by a composite reference standard. This composite reference standard incorporates the results of the complete MRI exam, pathology, and clinical follow-up.
Measured: Within 6 months after initial index imaging (MRI & US)
Secondary outcomes (3)
Circulating tumor DNA (ctDNA)
Measured: Within 1 year of blood processing
Serum AFP
Serum Alpha-Fetoprotein
Measured: Within 1 year of blood processing
Cost-effectiveness
The cost-effectiveness will be assessed using a micro simulation model.
Measured: Within 1 year after initial index imaging (MRI & US).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start17 Aug 2020
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Duke University, University of Wisconsin, Madison, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bachir Taouli, Icahn School of Medicine at Mount Sinai
- Investigators
- Bachir Taouli, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539717
- Sponsor's protocol ID
- GCO 19-1409
- Other IDs
- 1R01CA249765-01
- Status last verified
- Oct 2025
- First submitted
- 31 Aug 2020
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lewis S, Wildman-Tobriner B, Cuevas J, Calle S, Bolger I, Wang K, Joshi H, Mankowski Gettle L, Yang JD, Min JH, Sirlin CB, Reeder SB, Bashir MR, Taouli B. Quality of Gadoxetate-enhanced MRI versus US during Hepatocellular Carcinoma Screening in Participants with Cirrhosis. Radiology. 2026 Feb;318(2):e251497. doi: 10.1148/radiol.251497.
PubMed 41665498
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbreviated MRI for HCC Screening in Cirrhotic Patients (FAST-MRI Study)
- ClinicalTrials.gov ID
- NCT04539717
- Acronym / sponsor ID
- GCO 19-1409
- Conditions
- Hepatocellular Carcinoma (HCC), Liver Cirrhosis
- Keywords
- Magnetic Resonance Imaging (MRI), Ultrasound (US), Liver Diseases, Elastography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- University of California, San Diego, Duke University, University of Wisconsin, Madison, National Cancer Institute (NCI)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the diagnostic value of a reconstructed abbreviated Magnetic Resonance Imaging (MRI) from a full clinical exam, compared to ultrasound (US) for screening of liver cancer. Blood markers will be evaluated to determine their correlation to imaging. This study will help to determine whether abbreviated MRI is superior to ultrasound for diagnosis of liver cancer.
Detailed description
Hepatocellular carcinoma (HCC) is the fastest growing cause of cancer death in the United States and now kills over 30,000 Americans annually. To reduce the morbidity and mortality caused by this aggressive cancer, current practice guidelines recommend semi-annual abdominal ultrasound in adults with cirrhosis, the leading risk factor for HCC, to detect HCC nodules when they are small and treatable. Unfortunately, US has poor sensitivity for early-stage HCC in cirrhosis, failing to detect treatable cancer in over half of affected patients. Alternatives such as computed tomography (CT) or magnetic resonance imaging (MRI) are also not ideal due to ionizing radiation (CT), higher cost (MRI), or long exam time (~30-45 min for MRI). An optimal and fast HCC screening method is urgently needed and should be more sensitive and cost-effective than US and avoid ionizing radiation.
This is a prospective cross-sectional single arm non randomized multicenter study enrolling in 4 American centers as follows: Icahn School of Medicine at Mount Sinai-ISMMS, University of California San Diego-UCSD, University of Wisconsin-UW, and Duke University. The composite reference standard will incorporate the clinical results of the full baseline MRI exam and of subsequent imaging and pathology data collected over the next 6 months. Routine clinical follow-up imaging at 6 months will be observed. Patients will then be classified as positive for HCC, negative for HCC, or excluded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed liver cirrhosis enrolled in imaging-based screening for HCC.
Key inclusion criteria (6 listed)
- Liver cirrhosis of any etiology.
- 18 years of age and older.
- Enrolled in screening/surveillance program for HCC.
- Clinically indicated imaging-based screening for HCC.
- Willing and able to complete all study procedures within specified time windows.
Key exclusion criteria (9 listed)
- Contra-indications to MRI.
- Age less than 18 years.
- Patients with chronic renal failure or inability to tolerate contrast.
- Inability to undergo MRI due to lack of insurance coverage.
- Prior negative screening exam less than 5 months prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of HCC
Time frame: Within 6 months after initial index imaging (MRI & US)
The presence of HCC will be determined by a composite reference standard. This composite reference standard incorporates the results of the complete MRI exam, pathology, and clinical follow-up.
3 secondary outcomes
Circulating tumor DNA (ctDNA)
Time frame: Within 1 year of blood processing
Serum AFP
Time frame: Within 1 year of blood processing
Cost-effectiveness
Time frame: Within 1 year after initial index imaging (MRI & US).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Derived from this study: PubMed 41665498Lewis S, Wildman-Tobriner B, Cuevas J, Calle S, Bolger I, Wang K, Joshi H, Mankowski Gettle L, Yang JD, Min JH, Sirlin CB, Reeder SB, Bashir MR, Taouli B. Quality of Gadoxetate-enhanced MRI versus US during Hepatocellular Carcinoma Screening in Participants with Cirrhosis. Radiology. 2026 Feb;318(2):e251497. doi: 10.1148/radiol.251497.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bachir Taouli principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC) and Liver Cirrhosis, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of HCC (time frame: Within 6 months after initial index imaging (MRI & US)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04539717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.