UltrasoundNCT04657328
Prospective Multicenter Study on Clinical Application of Sonazoid in Breast Tumor
An observational study of Ultrasound, 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 high mechanical index,the role of Sonazoid in the differential diagnosis of breast benign and malignant tumors was explored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2020to Oct 2021
- How long will I take part?
- 1 Month
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Conventional ultrasonography suggested definite lesions in the breast; 2. In addition to conventional ultrasound, there is also enhanced nuclear magnetic examination; 3. There are no contraindications for puncture biopsy, and pathological examination (cytology, histology) is planned to examine the patients with target lesions 4. Patients volunteered to participate in the study and signed informed consent.
Who may be able to join
- Conventional ultrasonography suggested definite lesions in the breast;
- In addition to conventional ultrasound, there is also enhanced MRI examination;
- There are no contraindications for puncture biopsy, and pathological examination (cytology, histology) is planned to examine the patients with target lesions
- Patients volunteered to participate in the study and signed informed consent.-
Who cannot join
- Those who are known to be allergic to ultrasound contrast agents;
- The subject has a history of allergy to eggs or egg products (i.e. skin rash, dyspnea, swelling of the mouth or throat, hypotension or shock, etc.)
- Arteriovenous (left and right) shunt patients in the heart and lungs
- Patients with serious heart disease or serious lung disease
- Patients who are pregnant, possibly pregnant or lactating
- Patients who cannot receive contrast agent MRI
- In addition, the investigator or the patient that the investigator considers not suitable to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jie Yu, Doctor, 8601066939530, jiemi301@163.com
About this study
Official title: Contrast-enhanced Ultrasound in Breast Tumor by Sonazoid
Sonazoid as a new generation of ultrasound contrast agent.This study based on the features of Sonazoid specific angiography and high mechanical index,the role of Sonazoid in the differential diagnosis of breast benign and malignant tumors was explored.
Read the detailed description
This trial is a prospective, multi-center study.With pathology as the gold standard, based on quantitative and qualitative analysis, Sonazoid-CEUS was compared with MRI to explore the diagnostic efficacy (accuracy, sensitivity and specificity) of Sonazoid-CEUS for breast tumor in different pathological types.
Investigators will also record the parameter information of imaging examination, pathological type of pathological examination and immunohistochemical index.Contrast-enhanced ultrasound includes lesion location, initial peak tumor volume, 1-minute tumor volume, 2-minute tumor volume, and 5-minute tumor volume, as well as the time for contrast enhancement, contrast agent clearance, and contrast agent clearance.Whether there is no enhancement area in the lesion after contrast enhancement, shape after contrast enhancement, edge after contrast enhancement, order of enhancement, uniformity of enhancement, intensity enhancement, pattern of enhancement, clear boundary after contrast enhancement, aspect ratio after contrast enhancement, etc.The magnetic field strength of the equipment is planned to be recorded in the enhanced MRI information, the name of the MRI contrast agent, the lesion location, the size of the LESION, and the scanning performance are enhanced (lump-like enhancement, non-lump-like enhancement, point-like enhancement), time-signal intensity enhancement curve, DWI signal, ADC value, etc.
- Conditions
- Ultrasound
- Keywords
- breast
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of contrast-enhanced ultrasound in breast tumor by Sonazoid.
Pathology as a gold standard,to evaluate the diagnostic performance in breast tumor by Sonazoid.
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 posted8 Dec 2020
- Study start15 Aug 2020
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- 181 participants (estimated)
- Target duration
- 1 Month
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, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657328
- Sponsor's protocol ID
- S2020-300
- Status last verified
- Aug 2021
- First submitted
- 26 Sep 2020
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lang M, Liang P, Shen H, Li H, Yang N, Chen B, Chen Y, Ding H, Yang W, Ji X, Zhou P, Cui L, Wang J, Xu W, Ye X, Liu Z, Yang Y, Wei T, Wang H, Yan Y, Wu C, Wu Y, Shi J, Wang Y, Fang X, Li R, Yu J. Head-to-head comparison of perfluorobutane contrast-enhanced US and multiparametric MRI for breast cancer: a prospective, multicenter study. Breast Cancer Res. 2023 May 30;25(1):61. doi: 10.1186/s13058-023-01650-3.
PubMed 37254149
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Ultrasound in Breast Tumor by Sonazoid
- ClinicalTrials.gov ID
- NCT04657328
- Acronym / sponsor ID
- S2020-300
- Conditions
- Ultrasound
- Keywords
- breast
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 181 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 8 Dec 2020 (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 high mechanical index,the role of Sonazoid in the differential diagnosis of breast benign and malignant tumors was explored.
Detailed description
This trial is a prospective, multi-center study.With pathology as the gold standard, based on quantitative and qualitative analysis, Sonazoid-CEUS was compared with MRI to explore the diagnostic efficacy (accuracy, sensitivity and specificity) of Sonazoid-CEUS for breast tumor in different pathological types.
Investigators will also record the parameter information of imaging examination, pathological type of pathological examination and immunohistochemical index.Contrast-enhanced ultrasound includes lesion location, initial peak tumor volume, 1-minute tumor volume, 2-minute tumor volume, and 5-minute tumor volume, as well as the time for contrast enhancement, contrast agent clearance, and contrast agent clearance.Whether there is no enhancement area in the lesion after contrast enhancement, shape after contrast enhancement, edge after contrast enhancement, order of enhancement, uniformity of enhancement, intensity enhancement, pattern of enhancement, clear boundary after contrast enhancement, aspect ratio after contrast enhancement, etc.The magnetic field strength of the equipment is planned to be recorded in the enhanced MRI information, the name of the MRI contrast agent, the lesion location, the size of the LESION, and the scanning performance are enhanced (lump-like enhancement, non-lump-like enhancement, point-like enhancement), time-signal intensity enhancement curve, DWI signal, ADC value, etc.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Conventional ultrasonography suggested definite lesions in the breast; 2. In addition to conventional ultrasound, there is also enhanced nuclear magnetic examination; 3. There are no contraindications for puncture biopsy, and pathological examination (cytology, histology) is planned to examine the patients with target lesions 4. Patients volunteered to participate in the study and signed informed consent.
Key inclusion criteria (4 listed)
- Conventional ultrasonography suggested definite lesions in the breast;
- In addition to conventional ultrasound, there is also enhanced MRI examination;
- There are no contraindications for puncture biopsy, and pathological examination (cytology, histology) is planned to examine the patients with target lesions
- Patients volunteered to participate in the study and signed informed consent.-
Key exclusion criteria (7 listed)
- Those who are known to be allergic to ultrasound contrast agents;
- The subject has a history of allergy to eggs or egg products (i.e. skin rash, dyspnea, swelling of the mouth or throat, hypotension or shock, etc.)
- Arteriovenous (left and right) shunt patients in the heart and lungs
- Patients with serious heart disease or serious lung disease
- Patients who are pregnant, possibly pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of contrast-enhanced ultrasound in breast tumor by Sonazoid.
Time frame: 10 months
Pathology as a gold standard,to evaluate the diagnostic performance in breast tumor by Sonazoid.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Derived from this study: PubMed 37254149Lang M, Liang P, Shen H, Li H, Yang N, Chen B, Chen Y, Ding H, Yang W, Ji X, Zhou P, Cui L, Wang J, Xu W, Ye X, Liu Z, Yang Y, Wei T, Wang H, Yan Y, Wu C, Wu Y, Shi J, Wang Y, Fang X, Li R, Yu J. Head-to-head comparison of perfluorobutane contrast-enhanced US and multiparametric MRI for breast cancer: a prospective, multicenter study. Breast Cancer Res. 2023 May 30;25(1):61. doi: 10.1186/s13058-023-01650-3.
- 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.
Ping Liang, Doctor 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 Ultrasound, 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 7 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 23 Aug 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 Jie Yu, Doctor (8601066939530, jiemi301@163.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 breast tumor 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?
On the ClinicalTrials.gov record for NCT04657328, which also lists 1 linked publication.
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 23 Aug 2021.