Endometrial Carcinoma Stage INCT04961775
A Prospective Multi-center Study on Using Sonazoid Diagnose Early Stage Endometrial Cancer
An observational study of Endometrial Carcinoma Stage I, run by Chinese PLA General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrial Carcinoma Stage I
- What is being tested?
- Perflubutane Microspheres for Injection
- Type of treatment
- Injection or infusion
- How many people
- 277 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with endometrial carcinoma who needs to biopsy or surgical resection;
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Xin Li, Doctor contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Ping Liang, Doctor
About this study
Official title: Contrast Enhanced Ultrasound Using Sonazoid Diagnose Early Stage Endometrial Carcinoma
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.
- Conditions
- Endometrial Carcinoma Stage I
- Being tested
- Perflubutane Microspheres for Injection
- Keywords
- Contrast Enhanced Ultrasound, Transvaginal ultrasound
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflubutane Microspheres for InjectionDrug
Also called Sonazoid
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Oct 2020
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Carcinoma Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 277 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961775
- Sponsor's protocol ID
- 2020-300-01-EC
- Status last verified
- Jul 2021
- First submitted
- 16 Nov 2020
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasound Using Sonazoid Diagnose Early Stage Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT04961775
- Acronym / sponsor ID
- 2020-300-01-EC
- Conditions
- Endometrial Carcinoma Stage I
- Keywords
- Contrast Enhanced Ultrasound, Transvaginal ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 277 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with endometrial carcinoma who needs to biopsy or surgical resection;
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perflubutane Microspheres for InjectionAlso: Sonazoid16 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. | Drug | – |
Primary outcome
Diagnostic performance of contrast-enhanced ultrasound in endometrial cancer by Sonazoid.
Time frame: 10 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Li, Doctor contact
Ping Liang principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Carcinoma Stage I, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhang, Doctor (13910535695, zjbch@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of contrast-enhanced ultrasound in endometrial cancer by Sonazoid. (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.