HelioLiver LDT now available to order through Quest Diagnostics
Laboratory analysis of a blood sample for liver cancer detection
Real-world case

Can an 8 mm liver tumor be detected before routine surveillance finds it?

This real-world case from the CLiMB Trial illustrates the importance of detecting hepatocellular carcinoma (HCC) while lesions are still small.

Published Clinical Case Published 2026 Clinical Case Series
Clinical question

Can an 8 mm liver tumor be detected before routine surveillance finds it?

This real-world case from the CLiMB Trial illustrates the importance of detecting hepatocellular carcinoma (HCC) while lesions are still small.

Clinical summary

Case summary

SettingRoutine HCC surveillance
PatientHigh-risk patient with cirrhosis
Standard abdominal ultrasoundPerformed; no lesion detected
HelioLiver® resultBlood test returned positive
Follow-up MRIIdentified an 8 mm hepatocellular carcinoma (HCC)
StageT1, while still within the curative treatment window
Key CLiMB Trial finding

What this case illustrates

This case illustrates one of the key findings from the CLiMB Trial:

  • Ultrasound detected 0% of HCC lesions smaller than 2 cm during a single surveillance visit.
  • HelioLiver® detected 28.6% of HCC lesions smaller than 2 cm, including tumors as small as 8 mm.

For patients at high risk of liver cancer, detecting HCC while lesions are still small may provide an opportunity for earlier intervention and potentially curative treatment.

Because in liver cancer, every millimeter matters.

Limitations
This case is shared for educational purposes. Individual patient outcomes may vary, and clinical decisions should always be based on the complete clinical picture.
Reference
  1. CLiMB Trial – A multi-analyte cfDNA-based blood test for early detection of hepatocellular carcinoma. Journal of Hepatology (2026). doi:10.1016/j.jhep.2026.04.012

About the CLiMB trial

CLiMB was a cross-sectional, prospective, blinded, multicenter validation study conducted across 42 clinical sites in the United States, evaluating the HelioLiver Dx test against abdominal ultrasound for the detection of hepatocellular carcinoma in adults with cirrhosis. Multiphasic MRI served as the reference standard. The HelioLiver Dx test met prespecified co-primary endpoints for superior sensitivity and non-inferior specificity compared to ultrasound.

Enrolled vs. evaluable. A total of 1,556 patients were enrolled in the prospective CLiMB study and assigned to the validation cohort, of whom 1,285 completed the initial visit. At the 6-month follow-up visit, 17 participants were lost to follow-up and were excluded from analysis. Only participants with valid results from the HelioLiver Dx test, ultrasound, and multiphasic MRI were considered evaluable. A total of 1,268 participants (81.5%) were evaluable, including 46 participants with HCC and 1,222 participants without HCC. Every performance figure in this series is calculated on that evaluable population. Published in the Journal of Hepatology, 2026. ClinicalTrials.gov identifier NCT03694600.

This case is shared for educational purposes only. Individual patient outcomes may vary, and clinical decisions should always be based on the complete clinical picture. The HelioLiver test is a laboratory developed test intended to aid in the detection of hepatocellular carcinoma in adults at high risk. It is not a replacement for guideline-recommended surveillance imaging and it is not a diagnostic test. A positive result requires diagnostic follow-up. A negative result does not exclude the presence of hepatocellular carcinoma.

Have a case to contribute?

Clinicians using the HelioLiver test can submit de-identified cases for consideration in this series.