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

NCT03267290 | Completed

• 1 other identifier: 201706079MIPA
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of the blinded read of CEUS+CEMRI and CECT+CEMRI in characterization of HCC

  the 95% two-sided confidence interval will be presented for both sensitivity and specificity in characterization of HCC

  up to 1 year

Secondary Outcomes (1)

• The sensitivity and specificity of the blinded read of CEUS+CEMRI and CECT+CEMRI in differential diagnosis of liver tumours

  up to 1 year

Study Arms (1)

Sonazoid- CEUS+CEMRI or CECT+CEMRI

EXPERIMENTAL

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

Diagnostic Test: Sonazoid- CEUS, CEMRI, CECT

Interventions

Sonazoid- CEUS, CEMRI, CECT DIAGNOSTIC_TEST

Sonazoid- CEUS+CEMRI in a characterization of HCC, in comparison with CECT+CEMRI.

Sonazoid- CEUS+CEMRI or CECT+CEMRI

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Kai-Wen Huang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2017
• First Posted: August 30, 2017
• Study Start: July 1, 2017
• Primary Completion: November 29, 2018
• Study Completion: January 11, 2019
• Last Updated: July 1, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)