Seravue Validation Study for Hepatocellular Carcinoma (HCC) Diagnosis

NCT06994130 | Not Yet Recruiting FDA Device

• 1 other identifier: IMC001
• Study Type: observational
• Target: 1,392
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hepatic Cancer

Keywords

liver cancer; AFP; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of study 24 months

Secondary Outcomes (1)

• Secondary Objective

  From enrollment to the end of study 24 months

Study Arms (1)

Group 1

Patient under surveillance for hepatocellular carcinoma coming in every 6 months for an ultrasound and AFP

Diagnostic Test: Seravue

Interventions

Seravue DIAGNOSTIC_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.

Group 1

Eligibility Criteria

• Age: 21 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient under surveillance for HCC

You may not qualify if:

• 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.
• 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.
• a. 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:
• \. Thrombocytopenia 2. Clinical symptoms (including but not limited to ascites, portal hypertension, hypersplenism, esophageal varices, and encephalopathy).
• \) 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:
• i. Asian males ≥ 40 years old OR ii. Asian females ≥ 50 years old OR iii. Patients of any ethnicity with a page B score ≥ 10
• 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.

Sponsors & Collaborators

• ImCare Biotech: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Kshama Mehta, PhD

CONTACT

4158451858; kshama.mehta@imcarebiotech.com

Felix Lu

CONTACT

(484) 688-4187; felix.lu@imcarebiotech.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)