Hepatic CancerSeravueNCT06994130
Seravue Validation Study for Hepatocellular Carcinoma (HCC) Diagnosis
An observational study of Hepatic Cancer, run by ImCare Biotech at 1 site in United States.
Trial summary
Currently, ultrasound with or without AFP is the standard of care when it comes to surveillance for HCC in high-risk populations. While ultrasound is non-invasive and plays a critical role in detecting HCC, it is operator-dependent, inconvenient, and may have access issues in low-resource settings. Read more about this study
- Who is it for?
- Ages 21 to 84 years
- Conditions the study is for
- Hepatic Cancer
- What is being tested?
- Seravue
- How many people
- 1,392 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2025to Aug 2029
- 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 21 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient under surveillance for HCC
Who may be able to join
- Patients who provide written informed consent and meet eligibility criteria will undergo baseline assessments and be entered into the study.
- A patient must meet all of the following criteria to be eligible for this study:
- The patient is willing and able to provide signed informed consent.
- The patient is aged ≥21to ≤84 years.
- The patient is willing to undergo phlebotomy and provide blood samples for future biomarker analysis.
- The patient is willing and able to undergo regularly scheduled onsite liver cancer surveillance by ultrasound and AFP and any resulting axial imaging such as computed tomography (CT, with or without contrast), magnetic resonance imaging (MRI), or ultrasound per the standard of care guidelines and study protocol schedule.
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- The patient has been diagnosed with hepatic cirrhosis of any etiology (both viral and non-viral), or Hepatitis B Virus (HBV). This includes HBV patients with pre-existing cirrhosis prior to antiviral therapy or other treatments leading to fibrosis regression who continue to be at risk.
- Cirrhosis may be diagnosed by any one of the following three methods: i. Biopsy and histological examination ii. Fibroscan (VCTE ≥ 12.5kPa) for all etiologies except HBV), Magnetic resonance elastography (≥ 4 kPa) iii. A combination of imaging (MRI, CT, or ultrasound) demonstrating a cirrhotic appearing liver AND at least one of the following:
- 1. Thrombocytopenia 2. Clinical symptoms (including but not limited to ascites, portal hypertension, hypersplenism, esophageal varices, and encephalopathy).
- 6) The patient has been diagnosed with HBV without cirrhosis.
- HBV will be defined by either a positive blood test for HBsAg, quantitative HBsAg, HBeAg OR detectable HBV DNA prior to initiating antiviral therapy.
- Patients are:
- Asian males ≥ 40 years old OR ii. Asian females ≥ 50 years old OR iii. Patients of any ethnicity with a page B score ≥ 10
Who cannot join
- A patient who meets any of the following criteria will be excluded from this study:
- Any health condition or other reason which, in the opinion of the investigator, would prelude study participation.
- Current Child Pugh C cirrhosis
- The patient has previously been diagnosed with a primary liver cancer or any cancer that has metastasized.
- The patient has participated in an interventional clinical study within 30 days prior to screening in which an experimental treatment was administered.
- The patient is unable or unwilling to submit to phlebotomy for testing or undergo ultrasound or other diagnostic imaging such as contrast-enhanced CT or MRI as recommended by AASLD standard of care guidelines.
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- The patient would not routinely be recommended for HCC surveillance.
- The female patient is pregnant or plans to become pregnant during the study.
- History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic multi-phase CT/MRI demonstrating benign nature
- AFP >20 ng/mL within 6 months prior to consent, in the absence of a contrast-enhanced multi-phase CT or MRI (before or after) in the past year demonstrating lack of suspicious liver lesions.
- If the AFP is >20 ng/mL during the study, the patient should undergo a contrast-enhanced multi-phase CT or MRI. if the patient has consistent elevations that are not increasing, repeat diagnostic testing will be left to the discretion of the investigator or the faculty.
- History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI prior to consent
- Patient's provider is planning to use only MRI- or CT- based surveillance moving forward
- History of Fontan associated liver disease or cardiac cirrhosis
- Actively listed for liver transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Daryl Lau, MD, MSc, MPH, (617) 632-1098, dlau@bidmc.harvard.edu
Julie Shea, 617-632-1129, jmshea@bidmc.harvard.edu
About this study
Official title: A Prospective Evaluation of Seravue Device Sensitivity and Specificity for Surveillance and Diagnosis of Patients at Risk for Hepatocellular Carinoma (HCC)
Currently, ultrasound with or without AFP is the standard of care when it comes to surveillance for HCC in high-risk populations. While ultrasound is non-invasive and plays a critical role in detecting HCC, it is operator-dependent, inconvenient, and may have access issues in low-resource settings. Most critically, ultrasound is not sensitive enough to detect or confirm HCC in its most critical early stages, where treatment options are most effective and result in the best patient outcomes. AFP on the other hand, suffers from poor sensitivity and specificity generally, and its performance is insufficient for use as a surveillance tool. There remains a clear unmet need for a blood test that is sensitive enough to detect HCC in its early stages while being cost-effective and accessible for use as a surveillance tool.
The investigators have previously demonstrated that serum liver cancer-secreted serine protease inhibitor Kazal (LC-SPIK) can reliably detect early HCC in addition to differentiating between it and other liver diseases. This study seeks to test the performance of the Seravue (LC-SPIK) device alone or in combination with other HCC diagnostic tests as a tool for HCC surveillance in diverse patient populations and clinical settings.
Read the detailed description
Patients who meet eligibility criteria and provide written informed consent will undergo comprehensive screening evaluations and standard of care clinical laboratory tests, including hepatic ultrasound and AFP testing at baseline, 6, 12, and 18 months after enrollment, or until the diagnosis of HCC. At each visit, blood specimens will be collected for testing with the Seravue device and for clinical and study biomarker testing including AFP. Pateints negative for ultrasound, AFP or Seravue results will continue on with the study. Patient testing positive for ultrasound, or AFP test results will undergo CT [with or without contrast] or MRI imaging to determine the presence or absence of HCC. Inconclusive or indeterminate radiographic diagnosis of HCC will require repeated imaging or lesion biopsy and histopathologic diagnosis to confirm or exclude the presence of HCC per standard of care guidelines. Once HCC diagnosis is confirmed, the patient will exit the study. A patient that demonstrates positive test for Seravue will return to the study visit schedule with no action being taken. All patients will have their medical records reported at month 24 for any new cancer diagnosis and standard of care labs performed. Adverse events (AEs) and serious adverse events (SAEs) will not be collected.
- Conditions
- Hepatic Cancer
- Being tested
- Seravue
- Keywords
- liver cancer, AFP, ultrasound
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeravueDiagnostic test
. This study seeks to test the performance of the SeravueTM (LC-SPIK) device alone or in combination with ultrasound as a tool for HCC surveillance in diverse patient populations and clinical settings.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patient under surveillance for hepatocellular carcinoma coming in every 6 months for an ultrasound and AFP Receives: Diagnostic Test: Seravue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
The primary objective of the study is to test that the sensitivity of the SeravueTM test in conjunction with ultrasound (LC-SPIK+US) is higher compared to a point-estimate of the sensitivity of the standard of care (US+AFP) in detecting HCC for patients with high risk of HCC due to chronic HBV or hepatic cirrhosis while the specificity are similar
Measured: From enrollment to the end of study 24 months
Secondary outcomes (1)
Secondary Objective
- • To test that the sensitivity of the SeravueTM test alone is higher compared to a point estimate of the sensitivity of the ultrasound alone in detecting HCC for patients with high risk of HCC due to chronic HBV or hepatic cirrhosis, while the specificity is similar.
- To test that the sensitivity of the SeravueTM test alone is higher compared to a point estimate of the sensitivity of the standard of care (US+AFP) in detecting HCC for patients with high risk of HCC due to chronic HBV or hepatic cirrhosis
Measured: From enrollment to the end of study 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CancerStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 1,392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImCare Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994130
- Sponsor's protocol ID
- IMC001
- Acronym
- Seravue
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Seravue Device Sensitivity and Specificity for Surveillance and Diagnosis of Patients at Risk for Hepatocellular Carinoma (HCC)
- ClinicalTrials.gov ID
- NCT06994130
- Acronym / sponsor ID
- Seravue / IMC001
- Conditions
- Hepatic Cancer
- Keywords
- liver cancer, AFP, ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,392 participants (estimated)
- Lead sponsor
- ImCare BiotechIndustry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 29 May 2025 (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.
Currently, ultrasound with or without AFP is the standard of care when it comes to surveillance for HCC in high-risk populations. While ultrasound is non-invasive and plays a critical role in detecting HCC, it is operator-dependent, inconvenient, and may have access issues in low-resource settings. Most critically, ultrasound is not sensitive enough to detect or confirm HCC in its most critical early stages, where treatment options are most effective and result in the best patient outcomes. AFP on the other hand, suffers from poor sensitivity and specificity generally, and its performance is insufficient for use as a surveillance tool. There remains a clear unmet need for a blood test that is sensitive enough to detect HCC in its early stages while being cost-effective and accessible for use as a surveillance tool.
The investigators have previously demonstrated that serum liver cancer-secreted serine protease inhibitor Kazal (LC-SPIK) can reliably detect early HCC in addition to differentiating between it and other liver diseases. This study seeks to test the performance of the Seravue (LC-SPIK) device alone or in combination with other HCC diagnostic tests as a tool for HCC surveillance in diverse patient populations and clinical settings.
Detailed description
Patients who meet eligibility criteria and provide written informed consent will undergo comprehensive screening evaluations and standard of care clinical laboratory tests, including hepatic ultrasound and AFP testing at baseline, 6, 12, and 18 months after enrollment, or until the diagnosis of HCC. At each visit, blood specimens will be collected for testing with the Seravue device and for clinical and study biomarker testing including AFP. Pateints negative for ultrasound, AFP or Seravue results will continue on with the study. Patient testing positive for ultrasound, or AFP test results will undergo CT [with or without contrast] or MRI imaging to determine the presence or absence of HCC. Inconclusive or indeterminate radiographic diagnosis of HCC will require repeated imaging or lesion biopsy and histopathologic diagnosis to confirm or exclude the presence of HCC per standard of care guidelines. Once HCC diagnosis is confirmed, the patient will exit the study. A patient that demonstrates positive test for Seravue will return to the study visit schedule with no action being taken. All patients will have their medical records reported at month 24 for any new cancer diagnosis and standard of care labs performed. Adverse events (AEs) and serious adverse events (SAEs) will not be collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: SeravuePatient under surveillance for hepatocellular carcinoma coming in every 6 months for an ultrasound and AFP |
Who may qualify
- Ages
- 21 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient under surveillance for HCC
Key inclusion criteria (13 listed)
- Patients who provide written informed consent and meet eligibility criteria will undergo baseline assessments and be entered into the study.
- The patient is willing and able to provide signed informed consent.
- The patient is aged ≥21to ≤84 years.
- The patient is willing to undergo phlebotomy and provide blood samples for future biomarker analysis.
- The patient is willing and able to undergo regularly scheduled onsite liver cancer surveillance by ultrasound and AFP and any resulting axial imaging such as computed tomography (CT, with or without contrast), magnetic resonance imaging (MRI), or ultrasound per the standard of care guidelines and study protocol schedule.
Key exclusion criteria (15 listed)
- Any health condition or other reason which, in the opinion of the investigator, would prelude study participation.
- Current Child Pugh C cirrhosis
- The patient has previously been diagnosed with a primary liver cancer or any cancer that has metastasized.
- The patient has participated in an interventional clinical study within 30 days prior to screening in which an experimental treatment was administered.
- The patient is unable or unwilling to submit to phlebotomy for testing or undergo ultrasound or other diagnostic imaging such as contrast-enhanced CT or MRI as recommended by AASLD standard of care guidelines.
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 |
|---|---|---|
| Seravue. This study seeks to test the performance of the SeravueTM (LC-SPIK) device alone or in combination with ultrasound as a tool for HCC surveillance in diverse patient populations and clinical settings. | Diagnostic test | Group 1 |
Primary outcome
Primary Objective
Time frame: From enrollment to the end of study 24 months
The primary objective of the study is to test that the sensitivity of the SeravueTM test in conjunction with ultrasound (LC-SPIK+US) is higher compared to a point-estimate of the sensitivity of the standard of care (US+AFP) in detecting HCC for patients with high risk of HCC due to chronic HBV or hepatic cirrhosis while the specificity are similar
1 secondary outcome
Secondary Objective
Time frame: From enrollment to the end of study 24 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 4 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Cancer, run by ImCare Biotech at 1 site 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 13 inclusion and 15 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: opening soon, as of the sponsor's last update on 4 Jun 2025. 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 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?
Contact Kshama Mehta, PhD (4158451858, kshama.mehta@imcarebiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: From enrollment to the end of study 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.