Seravue Validation Study for Hepatocellular Carcinoma (HCC) Diagnosis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
ImCare Biotech
Study ID
NCT06994130
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Hepatic Cancer

Eligibility Criteria

Sex
ALL
Age
21 Years - 84 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 31, 2025
Status verified
May 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
1,392 participants (estimated)

Arms

  • Arm: Group 1
    Patient under surveillance for hepatocellular carcinoma coming in every 6 months for an ultrasound and AFP

Primary Outcome Measure

Primary Objective [ Time Frame: From enrollment to the end of study 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Daryl Lau, MD, MSc, MPH
[email protected]
(617) 632-1098
Julie Shea
[email protected]
617-632-1129

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MA

Related Studies