Hepatocellular Carcinoma (HCC) Clinical Trial
Official title:
A Prospective Clinical Study for Comparing Diagnostic Accuracy for Liver Tumours Between the Combination of Contrast-enhanced Ultrasound and Contrast-enhanced Magnetic Resonance Imaging Versus Contrast-enhanced Computed Tomography and CEMRI
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.
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.
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