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

• Conditions: Endometrial Carcinoma Stage I

• Registration Number: NCT04961775
• Lead Sponsor: Chinese PLA General Hospital

Brief 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.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-11-16
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-03
• Last Update Submitted: 2021-07-03
• Study First Posted: 2021-07-14
• Last Update Posted: 2021-07-14
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 277

Inclusion Criteria

• 1)Patients with Irregular Vaginal bleeding with endometrial thickness is greater than 5mm(Postmenopausal) or10mm (Premenopausal) via transvaginal ultrasound；
• 2)Able to perform curettage or other image examination and surgical pathological staging；
• 3. Patients with complete clinical data, pathological test and follow-up data；
• 4)Ability to understand, sign informed consent and agree to participate in the investigator.

Exclusion Criteria

• 1)Patients without Endometrial carcinoma;
• 2)Women during pregnancy and lactation;
• 3)Those who are known to be allergic to ultrasound contrast agents;
• 4)Patients with arterial-venous (right to left) shunt in the heart or lung or with serious heart diseases or with serious lung diseases;
• 5)Any other condition makes patient not eligible for this clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of contrast-enhanced ultrasound in endometrial cancer by Sonazoid.	10 months	Pathology as a gold standard, to observe the diagnostic performance of Sonazoid in endometrial tumor:a prospective multicenter study based on quantitative and qualitative analysis.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China