A Prospective Multi-center Study on Using Sonazoid Diagnose Early Stage Endometrial Cancer
Contrast Enhanced Ultrasound Using Sonazoid Diagnose Early Stage Endometrial Carcinoma
1 other identifier
observational
277
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
July 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedJuly 14, 2021
July 1, 2021
10 months
November 16, 2020
July 3, 2021
Conditions
Keywords
Outcome Measures
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.
10 months
Interventions
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.
Eligibility Criteria
Patients with endometrial carcinoma who needs to biopsy or surgical resection;
You may qualify if:
- )Patients with Irregular Vaginal bleeding with endometrial thickness is greater than 5mm(Postmenopausal) or10mm (Premenopausal) via transvaginal ultrasound；
- )Able to perform curettage or other image examination and surgical pathological staging；
- \) Patients with complete clinical data, pathological test and follow-up data；
- )Ability to understand, sign informed consent and agree to participate in the investigator.
You may not qualify if:
- )Patients without Endometrial carcinoma;
- )Women during pregnancy and lactation;
- )Those who are known to be allergic to ultrasound contrast agents;
- )Patients with arterial-venous (right to left) shunt in the heart or lung or with serious heart diseases or with serious lung diseases;
- )Any other condition makes patient not eligible for this clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Biospecimen
pathological diagnosis
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ping Liang
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Interventional Ultrasound
Study Record Dates
First Submitted
November 16, 2020
First Posted
July 14, 2021
Study Start
October 1, 2020
Primary Completion
August 1, 2021
Study Completion
August 1, 2021
Last Updated
July 14, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share