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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

277 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-08-01

Brief Summary

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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.

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Detailed Description

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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

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Endometrial Carcinoma Stage I

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Sonazoid

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No