Breast DiseaseNCT06025461
Multimodal Ultrasound Diagnosis Characteristics of Bi-rads Class 4 Breast Lesions
An observational study of Breast Disease, run by Ma Zhe at 1 site in China.
Trial summary
Objective: To explore the potential association between the multimodal ultrasound characteristics and pathological classification of BI-RADS category 4 breast lesions, so as to clarify the diagnostic characteristics of multimodal ultrasound in different pathological types BI-RADS category 4 breast lesions. Read more about this study
- Who is it for?
- Ages 30 to 76 years, women only
- Conditions the study is for
- Breast Disease
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2021to 30 Mar 2023
- 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 30 to 76 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected.
Who may be able to join
- Perform ultrasound examination at our hospital before surgery or puncture biopsy; Complete histopathological data; Two ultrasound physicians with more than 5 years of experience in breast ultrasound diagnosis were diagnosed as BI-RADS Class 4 based on preoperative ultrasound images.
Who cannot join
- Poor image quality; Incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Multi-modal Ultrasound Features and Pathologic Classification of BI-RADS Category 4 Breast Lesions
Objective: To explore the potential association between the multimodal ultrasound characteristics and pathological classification of BI-RADS category 4 breast lesions, so as to clarify the diagnostic characteristics of multimodal ultrasound in different pathological types BI-RADS category 4 breast lesions.
Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.
- Conditions
- Breast Disease
- Being tested
- no intervention
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| fibroadenoma group | Not described Receives: Other: no intervention | |
| breast hyperplasia group | Not described Receives: Other: no intervention | |
| other types of benign nodules group | Not described Receives: Other: no intervention | |
| non-specific invasive carcinoma group | Not described Receives: Other: no intervention | |
| other types of breast cancer group | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
elasticity imaging/B-mode ratio
The ratio of lesion length on strain elastography images to lesion length on grayscale images
Measured: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
shear wave velocity
Shear wave velocity values at the hardest point of the lesion and surrounding tissues
Measured: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
strain ratio
The ratio of average strain between surrounding tissues at the same depth and the lesion
Measured: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start15 Nov 2021
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ma Zhe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ma Zhe, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025461
- Sponsor's protocol ID
- YXLL-KY-2023(012)
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- 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 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Multi-modal Ultrasound Features and Pathologic Classification of BI-RADS Category 4 Breast Lesions
- ClinicalTrials.gov ID
- NCT06025461
- Acronym / sponsor ID
- YXLL-KY-2023(012)
- Conditions
- Breast Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ma ZheUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 6 Sep 2023 (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.
Objective: To explore the potential association between the multimodal ultrasound characteristics and pathological classification of BI-RADS category 4 breast lesions, so as to clarify the diagnostic characteristics of multimodal ultrasound in different pathological types BI-RADS category 4 breast lesions.
Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| fibroadenoma group | – | Other: no intervention |
| breast hyperplasia group | – | Other: no intervention |
| other types of benign nodules group | – | Other: no intervention |
| non-specific invasive carcinoma group | – | Other: no intervention |
| other types of breast cancer group | – | Other: no intervention |
Who may qualify
- Ages
- 30 to 76 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected.
Key inclusion criteria (1 listed)
- Perform ultrasound examination at our hospital before surgery or puncture biopsy; Complete histopathological data; Two ultrasound physicians with more than 5 years of experience in breast ultrasound diagnosis were diagnosed as BI-RADS Class 4 based on preoperative ultrasound images.
Key exclusion criteria (1 listed)
- Poor image quality; Incomplete clinical data.
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 |
|---|---|---|
| no interventionno intervention | Other | breast hyperplasia group, fibroadenoma group, non-specific invasive carcinoma group, other types of benign nodules group, other types of breast cancer group |
Primary outcome
elasticity imaging/B-mode ratio
Time frame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
The ratio of lesion length on strain elastography images to lesion length on grayscale images
shear wave velocity
Time frame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
Shear wave velocity values at the hardest point of the lesion and surrounding tissues
strain ratio
Time frame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
The ratio of average strain between surrounding tissues at the same depth and the lesion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Disease, run by Ma Zhe 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
elasticity imaging/B-mode ratio (time frame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography). The study lists 3 primary outcomes in all. 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 6 Sep 2023.