Contrast-enhanced ultrasonic diagnosis of head and neck tumor

JRCT ID: jRCTs021180035

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Head and neck tumor
• Date of first enrollment: 14/07/2015
• Target sample size: 100
• Countries of recruitment: many,Japan
• Study type: Interventional
• Intervention(s): intra-venous injection of contrast-medium

Outcome(s)

• Primary Outcome: Differential diagnosis of benign and malignant tumor

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. patients with untreated head and neck tumor
2. patients with the tumor which will be resected and diagnosed by histopathological examination
3. patients more than 20 years old

Exclude criteria

1. patients with allergy to egg or ingredient made from egg
2. patients with arterio-venous shunt in heart or lung
3. patients with severe heart disease
4. patients with severe lung disease
5. patients who will undergo laparoscopic examination or digestive tract examination using effervescent agent on the same day undergoing this examination
6. pregnant or possible pregnant patients and breast-feeding patients
7. patients who can not receive contrast-enhanced MRI or CT examination
8. patients whose target tumors are recurrent diseases
9. patients who received or will be received contrast-enhanced media (Iode media, MRI media, other contrast-enhanced media for ultrasonography etc.) during the day before and after the day of sonazoid injection
10. patients who responsible doctors recognize inappropriate for this study

Related Information

• Primary Sponsor: Shiga Kiyoto