Seravue Validation Study for Liver Cancer Diagnosis

This study is testing a new diagnostic tool called Seravue for detecting liver cancer (Hepatocellular Carcinoma or HCC). Currently, ultrasound and a blood test called AFP are used, but they aren't always accurate enough, especially in early stages. Researchers want to see if Seravue, either alone or with ultrasound, can better identify HCC in people aged 21 to 84. The study will compare Seravue's performance against current methods over 24 months. This is an observational study, meaning you won't receive a new treatment, but your health will be monitored to see how well Seravue works.

Study design
This is an observational study planning to enroll 1392 participants. It will compare the Seravue device to standard methods for detecting liver cancer.
What's involved
You would have baseline assessments and blood draws, plus hepatic ultrasound and AFP testing at enrollment, 6, 12, and 18 months, or until HCC diagnosis. Your medical records will be reviewed at 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months from enrollment, or until an HCC diagnosis is confirmed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06994130

Seravue Validation Study for Hepatocellular Carcinoma (HCC) Diagnosis

Not Yet Recruiting
Not specifiedAges 21–84Observational
ImCare Biotech
~1,392 participants
Updated 2025-06-04 on ClinicalTrials.gov
What's tested:Seravue

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Objective
Measured over From enrollment to the end of study 24 months
Hepatic Cancer

NCT06994130

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Opens a ready-to-send draft in your own email app — review before sending.

  • Primary ObjectiveFrom 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