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Status unknownNCT04961775Updated Jul 14, 2021

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

An observational study in Endometrial Carcinoma Stage I, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-07-14.

Sponsored by Chinese PLA General Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
277
Ages
18 Years to 80 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Endometrial Carcinoma Stage I

Keywords

  • Contrast Enhanced Ultrasound
  • Transvaginal ultrasound
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 277 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with endometrial carcinoma who needs to biopsy or surgical resection;

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;
    1. 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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
277 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • DrugPerflubutane 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.

    Also known as: Sonazoid

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 months

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Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, Beijing 100853, China
    • Ping Liang, Doctor · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04961775
Lead sponsor
Chinese PLA General Hospital
Responsible party
Ping Liang (Department of Interventional Ultrasound, Chinese PLA General Hospital) — Principal investigator
First posted
Jul 14, 2021
Start date
Oct 1, 2020
Primary completion
Aug 1, 2021 (estimated)
Completion
Aug 1, 2021 (estimated)
Last update
Jul 14, 2021

Study contacts

Jing Zhang, Doctor
Contact
zjbch@vip.sina.com
13910535695
Xin Li, Doctor
Contact
18210198929
Ping Liang
principal investigator · Chinese PLA General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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