Comparing Diagnostic Accuracy for Liver Tumours Between the Combination of CEUS and CEMRI Versus CECT and CEMRI
Condition: Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Interventional

Summary: 
      Hepatocellular carcinoma (HCC) is unique regarding diagnosis because the clinical diagnosis
      without pathology proof is accepted. The dynamic image, including contrast-enhanced computed
      tomography (CECT) and contrast-enhanced magnetic resonance image (CEMRI) were recognized in
      many guidelines for diagnosing the HCC. In contrast to the CT and MRI, ultrasound (US)
      with/without contrast is suggested by several societies as the sufficient surveillance
      modality. The contrast-enhanced ultrasound (CEUS) has aroused more attentions regarding the
      rapid improvement of contrast medium. In this study, the investigators conducted a
      prospective, single-center, open-label trial to compare the efficacy and safety of CEUS +
      CEMRI in characterizing HCC, in comparison with CECT + CEMRI.
    

Detailed description: 
      The liver cancers including hepatocellular carcinoma (HCC) resulted in more than 7,000
      mortalities in Taiwan every year. HCC is unique regarding diagnosis because the clinical
      diagnosis without pathology proof is accepted. The dynamic image, including contrast-enhanced
      computed tomography (CECT) and contrast-enhanced magnetic resonance image (CEMRI) were
      recognized in many guidelines for diagnosing the HCC including Taiwan National Health
      insurance. Currently established guidelines endorse 3-phasic CT and MRI as first-line
      modalities. In contrast to the CT and MRI, ultrasound (US) with/without contrast is suggested
      by several societies as the most sufficient surveillance modality. However, the advantage of
      US in liver cirrhosis with regenerative nodules is only 32-65% in sensitivity.

      The contrast-enhanced ultrasound (CEUS) has aroused more attentions regarding the rapidly
      improvement of contrast medium. In addition to Italian association for the study of the
      liver, the Japan society has documented CEUS as an integral part in the diagnosis algorism.
      Two phases, i.e. vascular phase and Kupffer phase, could be interpreted with second
      generation contrast agents, Sonazoid, for differentiating liver tumors. For liver tumor that
      failed to present washout phase in CECT or CEMRI, CEUS might be helpful because a tumor lack
      of contrast uptake in the Kupffer phase is favouring HCC. However, previous reports were
      confined to retrospective studies or small population, and more solid evidence is required to
      identify the diagnosis feasibility of CEUS with specific contrast agent.

      In this study, the investigators conducted a prospective, single-center, open-label trial to
      compare the efficacy and safety of CEUS + CEMRI in characterizing HCC, in comparison with
      CECT + CEMRI. 60 patients with liver tumours no larger than 3cm in diameter will be enrolled,
      and tumour specimen will be obtained after imaging examination by tumour resection or biopsy.
      The primary endpoint is the sensitivity and specificity between the study groups, use the
      histology as reference diagnosis. The secondary endpoints include (1) the sensitivity and
      specificity of CEUS+CECT, CECT+CEMRI in differential diagnosis of liver tomours as malignant
      or benign, use the histology as reference diagnosis, (2) adverse effects, (3) vital signs
      (blood pressure, heart rate), and (4) laboratory values (the hematologic, renal and hepatic
      function change). Our exploratory endpoint is the detection rate of CEUS+CEMRI, CECT+CEMRI,
      use the histology as reference diagnosis.
    

Intervention name(s): Sonazoid- CEUS, CEMRI, CECT
Intervention type(s): Diagnostic Test
Intervention description(s): Sonazoid- CEUS+CEMRI in a characterization of HCC, in comparison with CECT+CEMRI.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other