Hepatocellular CarcinomaFASTRAKNCT05095714
FAST-IRM for HCC suRveillance in pAtients With High risK of Liver Cancer.
A study testing Liver ultrasound and fast-MRI and Liver ultrasound in people with Hepatocellular Carcinoma and Liver Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Intro: Hepatocellular carcinoma (HCC) is the 6th leading cause of cancer worldwide. In France, more than 10,000 new cases are identified each year. The latter occur in 85% of cases in cirrhosis, the most frequent causes of which are excessive alcohol consumption, metabolic syndrome or HBV/HCV infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer, Cirrhosis
- What is being tested?
- Liver ultrasound and fast-MRI and Liver ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 944 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2022to 23 Jun 2030
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Patient enrolled in a screening program for at least 6 months in a tertiary hepatology center
- Cirrhosis histologically proven or unequivocally suggested by non-invasive tests
- Absence of HCC on imaging less than 3 months o
- Liver parenchyma explorable by ultrasound
- Child-Pugh A or B
Show all 10Show fewer
- Cirrhosis of non-viral or viral B/C cause controlled/healed
- With an estimated annual risk of HCC>3%
- Written informed consent
- Affiliation to a social security system
Who cannot join
- Child-Pugh C score
- Active hepatitis B or C
- Estimated annual risk of HCC<3%
- No prior enrollment in a screening program
- Contraindication to Fast-MRI
- Non-echogenic patient
Show all 10Show fewer
- Patient deprived of liberty
- Patient under legal protection
- Pregnant or breastfeeding woman
- Patient on AME (state medical aid)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris - Hôpital Avicenne
Bondy, 93140
About this study
Official title: Randomized Study Evaluating the Cost Impact and Effectiveness of Systematic Liver Fast-MRI Surveillance for Early-stage Hepatocellular Carcinoma in High-risk Patients Included in Ultrasound Surveillance Programs
Intro: Hepatocellular carcinoma (HCC) is the 6th leading cause of cancer worldwide. In France, more than 10,000 new cases are identified each year. The latter occur in 85% of cases in cirrhosis, the most frequent causes of which are excessive alcohol consumption, metabolic syndrome or HBV/HCV infection. Patients with cirrhosis justify being included in monitoring programs involving the performance of a semi-annual liver ultrasound (US) in order to detect HCC eligible for curative treatment (liver resection or percutaneous ablation). This practice is considered to be cost-effective in the event of an annual incidence of HCC> 1.5%. US in this context has a low sensitivity for the detection of HCC at the very early stage and the following observations have been made in the last 20 years:
- The rate of patients detected at early stage BCLC 0 is around 30% by ultrasound
- The rate of patients included in surveillance programs detected with advanced HCC eligible for palliative treatment is around 20%
- Reducing the periodicity of liver ultrasounds from 6 to 3 months does not improve these results.
Read more
In parallel, liver MRI has been evaluated as a tool for the early detection of HCC. Its performance for the detection of HCC at the very early stage exceeds 80%. However, due to the higher cost compared to US, it was estimated that its use in screening context would only be cost effective in the event of an annual incidence> 3%. In addition, the practice of these expensive and long-lasting MRIs (30 to 45 minutes) can be optimized by carrying out abbreviated MRI protocols" or Fast-MRI: short protocols (<10 minutes), based on the sequences with the better detection sensitivities (Se> 83%).
The hypothesis is that Fast-MRI used as a screening examination in patients at high risk of HCC (> 3% per year) could increase the rates of patients detected at an early stage accessible to curative treatment and demonstrate its cost-effectiveness in this population.
Hypothesis/Objective: The main objective is to assess the cost / QALY and / patient detected with an early HCC BCLC 0 (single tumor <2cm) by semi-annual monitoring by liver US and Fast-MRI, compared to conventional semi-annual monitoring by liver US alone in patients with cirrhosis and an anticipated HCC incidence>3%.
Conclusion: If positive, this trial could modify international practice guidelines and set MRI as the optimal tool for early HCC detection in high-risk patients.
Read the detailed description
Method: This is a randomized controlled, multicenter, 2 parallel arm, superiority trial carried out in patients at high risk of HCC>3%. Patients with cirrhosis of non-viral cause or controlled/eradicated for HBV/HCV infection will be included if their estimated yearly HCC incidence is above 3% according to clinical risk stratification scoring systems previously developed (and published) in French population. Randomization will be individual according to a 1: 1 allocation ratio, centralized and stratified on the center. After inclusion in the trial, each patient will be randomized to be assigned to the experimental group (six-month liver US and fast-MRI) or control (six-month liver US only). At each semi-annual visit, a patient will be considered free from nodules if neither ultrasound nor Fast-MRI detects a nodule. If a nodule is detected by either of the two exams, the patient will undergo a characterization process according to international recommendations, using a combination of injected sectional imaging and/or liver biopsy. The diagnosis of HCC will be definitively assessed in each center during a multidisciplinary consultation meeting. The primary analysis will be carried out by intention to treat.
The rates of BCLC 0 stage HCC will be compared between the two arms. Medico-economic efficiency criterion will be based on an analysis of the different costs from the point of view of the healthcare system and on an analysis of clinical effectiveness in real life and will be supplemented by a budget impact analysis from the point of view of Health Insurance. The time horizon extends from inclusion up to 3 years with an annual update of costs and benefits at 2.5%.Quality of life will be assessed using the EQ-5D5L scale, their variations to the total costs evaluated for each arm will be compared. QALYs will be calculated in each group. The costs and QALYs will be compared for the 2 strategies.
- Being tested
- Liver ultrasound and fast-MRI, Liver ultrasound
- Keywords
- Hepatocellular carcinoma, Liver cancer, Cirrhosis, Chronic liver disease, Surveillance, Detection, MRI, Risk stratification
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver ultrasound and fast-MRIOther
Half-yearly liver ultrasound and fast-MRI
Liver ultrasoundOther
Half-yearly liver ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Enhanced screening | Experimental | Half-yearly liver ultrasound and fast-MRI Receives: Other: Liver ultrasound and fast-MRI |
| Screening recommendations | Active comparator | Half-yearly liver ultrasound Receives: Other: Liver ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental cost / QALY ratio
Medico-economic efficiency criterion will assess the quality of life using the EQ-5D5L scale and compare their variations to the total costs evaluated for each arm.
Measured: at 36 months
Secondary outcomes (6)
Percentage of HCC detected at early stage
Rates of BCLC 0 stage HCC detected every 6 months
Measured: at 36 months
Sensitivity
Measured: at 36 months
Specificity
Measured: at 36 months
Rates of curative HCC treatments
Measured: at 36 months
Survival
Measured: at 36 months
Compliance
Compliance with follow-up visits
Measured: at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start23 Nov 2022
- Primary completion23 Nov 2028 (estimated)
- Study completion23 Jun 2030 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 944 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre NAHON, MD, PhD, Study director, Assistance Publique Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095714
- Sponsor's protocol ID
- APHP210987
- Acronym
- FASTRAK
- Status last verified
- May 2025
- First submitted
- 27 Sep 2021
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nahon P, Ronot M, Sutter O, Natella PA, Baloul S, Durand-Zaleski I, Audureau E. Study protocol for FASTRAK: a randomised controlled trial evaluating the cost impact and effectiveness of FAST-MRI for HCC suRveillance in pAtients with high risK of liver cancer. BMJ Open. 2024 Feb 17;14(2):e083701. doi: 10.1136/bmjopen-2023-083701.
PubMed 38367972
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Evaluating the Cost Impact and Effectiveness of Systematic Liver Fast-MRI Surveillance for Early-stage Hepatocellular Carcinoma in High-risk Patients Included in Ultrasound Surveillance Programs
- ClinicalTrials.gov ID
- NCT05095714
- Acronym / sponsor ID
- FASTRAK / APHP210987
- Keywords
- Hepatocellular carcinoma, Liver cancer, Cirrhosis, Chronic liver disease, Surveillance, Detection, MRI, Risk stratification
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 944 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 23 Nov 2028 (estimated)
- Study completion
- 23 Jun 2030 (estimated)
- First posted
- 27 Oct 2021 (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.
Intro: Hepatocellular carcinoma (HCC) is the 6th leading cause of cancer worldwide. In France, more than 10,000 new cases are identified each year. The latter occur in 85% of cases in cirrhosis, the most frequent causes of which are excessive alcohol consumption, metabolic syndrome or HBV/HCV infection. Patients with cirrhosis justify being included in monitoring programs involving the performance of a semi-annual liver ultrasound (US) in order to detect HCC eligible for curative treatment (liver resection or percutaneous ablation). This practice is considered to be cost-effective in the event of an annual incidence of HCC> 1.5%. US in this context has a low sensitivity for the detection of HCC at the very early stage and the following observations have been made in the last 20 years:
- The rate of patients detected at early stage BCLC 0 is around 30% by ultrasound
- The rate of patients included in surveillance programs detected with advanced HCC eligible for palliative treatment is around 20%
- Reducing the periodicity of liver ultrasounds from 6 to 3 months does not improve these results.
In parallel, liver MRI has been evaluated as a tool for the early detection of HCC. Its performance for the detection of HCC at the very early stage exceeds 80%. However, due to the higher cost compared to US, it was estimated that its use in screening context would only be cost effective in the event of an annual incidence> 3%. In addition, the practice of these expensive and long-lasting MRIs (30 to 45 minutes) can be optimized by carrying out abbreviated MRI protocols" or Fast-MRI: short protocols (<10 minutes), based on the sequences with the better detection sensitivities (Se> 83%).
The hypothesis is that Fast-MRI used as a screening examination in patients at high risk of HCC (> 3% per year) could increase the rates of patients detected at an early stage accessible to curative treatment and demonstrate its cost-effectiveness in this population.
Hypothesis/Objective: The main objective is to assess the cost / QALY and / patient detected with an early HCC BCLC 0 (single tumor <2cm) by semi-annual monitoring by liver US and Fast-MRI, compared to conventional semi-annual monitoring by liver US alone in patients with cirrhosis and an anticipated HCC incidence>3%.
Conclusion: If positive, this trial could modify international practice guidelines and set MRI as the optimal tool for early HCC detection in high-risk patients.
Detailed description
Method: This is a randomized controlled, multicenter, 2 parallel arm, superiority trial carried out in patients at high risk of HCC>3%. Patients with cirrhosis of non-viral cause or controlled/eradicated for HBV/HCV infection will be included if their estimated yearly HCC incidence is above 3% according to clinical risk stratification scoring systems previously developed (and published) in French population. Randomization will be individual according to a 1: 1 allocation ratio, centralized and stratified on the center. After inclusion in the trial, each patient will be randomized to be assigned to the experimental group (six-month liver US and fast-MRI) or control (six-month liver US only). At each semi-annual visit, a patient will be considered free from nodules if neither ultrasound nor Fast-MRI detects a nodule. If a nodule is detected by either of the two exams, the patient will undergo a characterization process according to international recommendations, using a combination of injected sectional imaging and/or liver biopsy. The diagnosis of HCC will be definitively assessed in each center during a multidisciplinary consultation meeting. The primary analysis will be carried out by intention to treat.
The rates of BCLC 0 stage HCC will be compared between the two arms. Medico-economic efficiency criterion will be based on an analysis of the different costs from the point of view of the healthcare system and on an analysis of clinical effectiveness in real life and will be supplemented by a budget impact analysis from the point of view of Health Insurance. The time horizon extends from inclusion up to 3 years with an annual update of costs and benefits at 2.5%.Quality of life will be assessed using the EQ-5D5L scale, their variations to the total costs evaluated for each arm will be compared. QALYs will be calculated in each group. The costs and QALYs will be compared for the 2 strategies.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced screening | Experimental | Other: Liver ultrasound and fast-MRIHalf-yearly liver ultrasound and fast-MRI |
| Screening recommendations | Active comparator | Other: Liver ultrasoundHalf-yearly liver ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Patient enrolled in a screening program for at least 6 months in a tertiary hepatology center
- Cirrhosis histologically proven or unequivocally suggested by non-invasive tests
- Absence of HCC on imaging less than 3 months o
- Liver parenchyma explorable by ultrasound
Key exclusion criteria (10 listed)
- Child-Pugh C score
- Active hepatitis B or C
- Estimated annual risk of HCC<3%
- No prior enrollment in a screening program
- Contraindication to Fast-MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver ultrasound and fast-MRIHalf-yearly liver ultrasound and fast-MRI | Other | Enhanced screening |
| Liver ultrasoundHalf-yearly liver ultrasound | Other | Screening recommendations |
Primary outcome
Incremental cost / QALY ratio
Time frame: at 36 months
Medico-economic efficiency criterion will assess the quality of life using the EQ-5D5L scale and compare their variations to the total costs evaluated for each arm.
6 secondary outcomes
Percentage of HCC detected at early stage
Time frame: at 36 months
Sensitivity
Time frame: at 36 months
Specificity
Time frame: at 36 months
Rates of curative HCC treatments
Time frame: at 36 months
Survival
Time frame: at 36 months
Compliance
Time frame: at 36 months
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 12 Mar 2026.
- Derived from this study: PubMed 38367972Nahon P, Ronot M, Sutter O, Natella PA, Baloul S, Durand-Zaleski I, Audureau E. Study protocol for FASTRAK: a randomised controlled trial evaluating the cost impact and effectiveness of FAST-MRI for HCC suRveillance in pAtients with high risK of liver cancer. BMJ Open. 2024 Feb 17;14(2):e083701. doi: 10.1136/bmjopen-2023-083701.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Pierre NAHON, MD, PhD study director
Assistance Publique Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver ultrasound and fast-MRI and Liver ultrasound in people with Hepatocellular Carcinoma and Liver Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Contact Pierre NAHON, MD, PhD (1 48 02 62 80 ext. +33, pierre.nahon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost / QALY ratio (time frame: at 36 months). 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 NCT05095714, 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 12 Mar 2026.