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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03267290
• Date of registration: 27/08/2017
• Prospective Registration: No
• Primary sponsor: National Taiwan University Hospital
• Public title: Comparing Diagnostic Accuracy for Liver Tumours Between the Combination of CEUS and CEMRI Versus CECT and CEMRI
• Scientific 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
• Date of first enrolment: July 1, 2017
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03267290
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Taiwan

Contacts

• Name: Kai-Wen Huang, MD, PhD
• Affiliation: National Taiwan University Hospital

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hepatocellular Carcinoma (HCC)

Intervention(s)

Diagnostic Test: Sonazoid- CEUS, CEMRI, CECT

Primary Outcome(s)

The sensitivity and specificity of the blinded read of CEUS+CEMRI and CECT+CEMRI in characterization of HCC [Time Frame: up to 1 year]

Secondary Outcome(s)

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]

Secondary ID(s)

201706079MIPA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors