NCT04961775

A Prospective Multi-center Study on Using Sonazoid Diagnose Early Stage Endometrial Cancer

Contrast Enhanced Ultrasound Using Sonazoid Diagnose Early Stage Endometrial Carcinoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 277 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Sonazoid as a new generation of ultrasound contrast agent.This study based on the features of Sonazoid specific angiography and higher mechanical index, the role of Sonazoid in the early diagnosis of Endometrial carcinoma was explored.

Detailed description

Sonazoid is a second generation ultrasound contrast agent, which is composed of microbubbles containing chemically stable and insoluble Perfluorobutane (PFB) gas and a hard shell of phosphatidylserine sodium (2-3 μ m in diameter) wrapped in the outer layer. These microbubbles can generate stable nonlinear oscillations in a low-power acoustic field and generate echoes at the second harmonic frequency of the transmitted pulse for enhanced contrast harmonic imaging. Because Sonazoid has the advantages of ultra long time development and good stability, Sonazoid has significant clinical advantages in the diagnosis of not focal liver lesions(FLLs) but breast tumor and other organ. However, there is no study based on contrast enhanced ultrasound(CEUS) using Sonazoid in early detection of Endometrial carcinoma. Therefore, based on the advantages of the new ultrasound contrast agent, using qualitative analysis and quantitative analysis method to collect large samples, compared with diagnosis results of standard reference, which has important clinical significance for early diagnosis, early detection and improving the accuracy of diagnosis of Endometrial carcinoma.

Conditions

• Endometrial Carcinoma Stage I

Interventions

Type	Name	Description
DRUG	Perflubutane Microspheres for Injection	16 µL as perflubutane microbubbles (1 vial) is reconstituted with 2 mL of attached water for injection; usually, once for an adult, 0.015 mL/kg as dispersion is administered intravenously.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2021-07-14
• Last updated: 2021-07-14

Locations

1 site across 1 country: China