Status:

COMPLETED

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

Lead Sponsor:

National Taiwan University Hospital

Conditions:

Hepatocellular Carcinoma (HCC)

Eligibility:

All Genders

20-70 years

Phase:

NA

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 (CEC...

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 pathol...

Eligibility Criteria

Inclusion

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

Exclusion

  • The lesion with previously documented histology
  • The lesion previously treated with Percutaneous Ethanol Injection, Radiofrequency Ablation, or Transarterial Chemoembolization
  • The lesion will not have histological confirmation after differential diagnosis
  • 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).
  • The subject was considered to be unsuitable to participate in the study by the investigator.
  • The subject was known to have a right-to-left shunt, severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg) or uncontrolled systemic hypertension.
  • 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.
  • The subject had adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
  • The subject had known thrombosis within the liver, or portal, or mesenteric veins.
  • The patient with iodine/Gd allergy, lower epidermal growth factor receptor level(\<50), liver/renal dysfunction, and other condition that unsuitable to receive contrast
  • Pregnant and breastfeeding women

Key Trial Info

Start Date :

July 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 11 2019

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT03267290

Start Date

July 1 2017

End Date

January 11 2019

Last Update

July 1 2020

Active Locations (1)

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1

National Taiwan University Hospital

Taipei, Taiwan

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