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

Endometrial Carcinoma Stage I Clinical Trial

Official title:

Contrast Enhanced Ultrasound Using Sonazoid Diagnose Early Stage Endometrial Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961775
• Other study ID #: 2020-300-01-EC
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: July 2021
• Source: Chinese PLA General Hospital
• Contact: Jing Zhang, Doctor
• Phone: 13910535695
• Email: zjbch[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 277
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Carcinoma Stage I
• Endometrial Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of contrast-enhanced ultrasound in endometrial cancer by Sonazoid.	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.	10 months