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Comparing Diagnostic Accuracy for Liver Tumours Between the Combination of CEUS and CEMRI Versus CECT and CEMRI

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ClinicalTrials.gov Identifier: NCT03267290
Recruitment Status : Completed
First Posted : August 30, 2017
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma (HCC) Diagnostic Test: Sonazoid- CEUS, CEMRI, CECT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : November 29, 2018
Actual Study Completion Date : January 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Sonazoid- CEUS+CEMRI or CECT+CEMRI
Comparing Diagnostic Accuracy for Liver Tumours Between the Combination of CEUS and CEMRI Versus CECT and CEMRI
Diagnostic Test: Sonazoid- CEUS, CEMRI, CECT
Sonazoid- CEUS+CEMRI in a characterization of HCC, in comparison with CECT+CEMRI.




Primary Outcome Measures :
  1. The sensitivity and specificity of the blinded read of CEUS+CEMRI and CECT+CEMRI in characterization of HCC [ Time Frame: up to 1 year ]
    the 95% two-sided confidence interval will be presented for both sensitivity and specificity in characterization of HCC


Secondary Outcome Measures :
  1. The sensitivity and specificity of the blinded read of CEUS+CEMRI and CECT+CEMRI in differential diagnosis of liver tumours [ Time Frame: up to 1 year ]
    the 95% two-sided confidence interval will be presented for both sensitivity and specificity in differential diagnosis of liver tumours



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 20-70
  2. All patients presented with newly diagnosed liver lesion(s) with initial impression of malignancy.
  3. Lesions no larger than 3cm in diameter.
  4. Signed and dated informed consent

Exclusion Criteria:

  1. The lesion with previously documented histology
  2. The lesion previously treated with Percutaneous Ethanol Injection, Radiofrequency Ablation, or Transarterial Chemoembolization
  3. The lesion will not have histological confirmation after differential diagnosis
  4. The subject had known hypersensitivity to any component of Sonazoid, including a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension or shock).
  5. The subject was considered to be unsuitable to participate in the study by the investigator.
  6. The subject was known to have a right-to-left shunt, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension.
  7. The subject had a recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within the last 7 days, significant worsening of cardiac symptoms within the last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of electrocardiogram, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders.
  8. The subject had adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
  9. The subject had known thrombosis within the liver, or portal, or mesenteric veins.
  10. The patient with iodine/Gd allergy, lower epidermal growth factor receptor level(<50), liver/renal dysfunction, and other condition that unsuitable to receive contrast
  11. Pregnant and breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267290


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Kai-Wen Huang, MD, PhD National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03267290    
Other Study ID Numbers: 201706079MIPA
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases