NCT06994130

Seravue Validation Study for Hepatocellular Carcinoma (HCC) Diagnosis

A Prospective Evaluation of Seravue Device Sensitivity and Specificity for Surveillance and Diagnosis of Patients at Risk for Hepatocellular Carinoma (HCC)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,392 (estimated)
• Sponsor: ImCare Biotech · Industry
• Sex: All
• Age: 21 Years – 84 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-08-01
• Completion: 2029-08-01
• First posted: 2025-05-29
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study