Clinical trial NCT04961775: A Prospective Multi-center Study on Using Sonazoid Diagnose Early Stage Endometrial Cancer
Official title: Contrast Enhanced Ultrasound Using Sonazoid Diagnose Early Stage Endometrial Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Carcinoma Stage I
Keywords: Contrast Enhanced Ultrasound
Transvaginal ultrasound
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 277
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with endometrial carcinoma who needs to biopsy or surgical resection;

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic performance of contrast-enhanced ultrasound in endometrial cancer by Sonazoid.
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Ping Liang
role: PRINCIPAL_INVESTIGATOR
References: