Breast TumorNCT06172270
Sub-regional Tumor Segmentation Based on CEUS Perfusion Characteristics: Enhancing Breast Tumor Diagnosis
An observational study of Breast Tumor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this study is to investigate breast cancer's internal heterogeneity and enhance diagnostic accuracy. The investigators aim to achieve this by utilizing Contrast-Enhanced Ultrasound (CEUS) technology, which provides detailed information about tumor perfusion dynamics. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Tumor
- How many people
- 339 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 3 Jan 2025
- 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
- Women only
- Adult, Older adult
Study population: Patients with breast nodule
Who may be able to join
- Prospective cohort patients voluntarily sign an informed consent form.
- Patients who undergo breast contrast-enhanced ultrasound.
- Patients with breast nodules that have not received any treatment.
Who cannot join
- Patients who cannot obtain pathological results due to refusal of further diagnosis or treatment.
- Patients whose breast lesions are too large to display their long axis under the ultrasound probe.
- Patients contraindicated for contrast-enhanced ultrasound.
- Historical cohort patients who cannot obtain ultrasound contrast videos of at least 45-60 seconds post contrast agent injection.
- Patients whose ultrasound contrast videos show excessive motion displacement that cannot be corrected.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Sub-regional Tumor Segmentation Based on Contrast-Enhanced Ultrasound Perfusion Characteristics: A Historical-Prospective Cohort Study for the Diagnosis of Breast Tumor
The goal of this study is to investigate breast cancer's internal heterogeneity and enhance diagnostic accuracy. The investigators aim to achieve this by utilizing Contrast-Enhanced Ultrasound (CEUS) technology, which provides detailed information about tumor perfusion dynamics. Traditional biopsy methods have limitations due to the invasive nature and complexity of breast cancer heterogeneity.
Participants in this study will undergo preoperative breast cancer diagnosis using CEUS technology, which is safe, cost-effective, and convenient. Dynamic CEUS videos will be used to cluster perfusion characteristics at the pixel level within breast tumors, allowing the investigators to divide the tumors into distinct subregions based on these clusters. The investigators will then explore the correlation between these perfusion subregions and the diagnosis of benign or malignant breast tumors.
The ultimate aim is to develop diagnostic models that utilize non-invasive imaging data to enhance breast cancer diagnosis. This approach reduces subjective judgments in the diagnostic process, potentially improving diagnostic accuracy. It also provides valuable information for personalized treatment decisions, thus advancing the field of breast cancer treatment.
Read the detailed description
Breast cancer is one of the most prevalent cancers among women globally, and its increasing incidence poses a significant threat to women's health. Despite notable advances in early diagnosis and treatment due to the continuous progress in medical technology, the high heterogeneity within breast cancer still results in considerable variability in clinical manifestations, treatment responses, and disease progression. This diversity presents new challenges in achieving precise treatment. Thus, a profound exploration and study of the heterogeneity of breast cancer are crucial for developing more effective diagnostic models, advancing treatment strategies, and enhancing cure rates.
In current clinical practice, although biopsy is widely used for the diagnosis of benign or malignant breast tumors, its accuracy and comprehensiveness are somewhat limited due to the complex internal heterogeneity of breast cancer and the invasive nature of the procedure. In recent years, preoperative qualitative diagnosis of breast cancer using medical imaging technology has become a hot topic in research. Compared with other common imaging techniques such as CT and MRI, ultrasound examination is extensively employed due to its safety, convenience, and lower cost. Particularly, Contrast-Enhanced Ultrasound (CEUS) technology, with its superior temporal resolution, can vividly illustrate the details of tumor perfusion hemodynamics, effectively revealing key features such as enhancement patterns, blood supply, and vascular invasion of the tumor.
This study is dedicated to using dynamic CEUS videos to cluster perfusion characteristics at the pixel level within the tumor and divide the tumor into different subregions based on the clustering results. We will explore the correlation between these perfusion subregions and the diagnosis of benign or malignant breast tumors, and based on this, develop related diagnostic models. This non-invasive diagnostic approach aims to maximally mine and utilize image data, comprehensively capturing the tumor's perfusion characteristics at the pixel level, and reducing subjective judgments in the diagnostic process. The application of this method is not only expected to improve the accuracy of breast cancer diagnosis but also to provide more information support for personalized treatment of patients, thereby promoting progress in the field of breast cancer treatment.
- Conditions
- Breast Tumor
- Keywords
- Breast Tumor, sub-region, Contrast-Enhanced Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benign breast tumors | Performing contrast-enhanced ultrasound on benign breast tumors and analyzing the video images | |
| Malignant breast tumors | Performing contrast-enhanced ultrasound on malignant breast tumors and analyzing the video images. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
The proportion of breast tumors (benign or malignant) correctly classified by the diagnostic model.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jul 2023
- Primary completion3 Jan 2025
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast TumorStudies 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
- Other
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172270
- Sponsor's protocol ID
- 2023-0555
- Status last verified
- Jan 2025
- First submitted
- 7 Dec 2023
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data cannot be shared because of ethical restrictions regarding human participant data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-regional Tumor Segmentation Based on Contrast-Enhanced Ultrasound Perfusion Characteristics: A Historical-Prospective Cohort Study for the Diagnosis of Breast Tumor
- ClinicalTrials.gov ID
- NCT06172270
- Acronym / sponsor ID
- 2023-0555
- Conditions
- Breast Tumor
- Keywords
- Breast Tumor, sub-region, Contrast-Enhanced Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 15 Dec 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.
The goal of this study is to investigate breast cancer's internal heterogeneity and enhance diagnostic accuracy. The investigators aim to achieve this by utilizing Contrast-Enhanced Ultrasound (CEUS) technology, which provides detailed information about tumor perfusion dynamics. Traditional biopsy methods have limitations due to the invasive nature and complexity of breast cancer heterogeneity.
Participants in this study will undergo preoperative breast cancer diagnosis using CEUS technology, which is safe, cost-effective, and convenient. Dynamic CEUS videos will be used to cluster perfusion characteristics at the pixel level within breast tumors, allowing the investigators to divide the tumors into distinct subregions based on these clusters. The investigators will then explore the correlation between these perfusion subregions and the diagnosis of benign or malignant breast tumors.
The ultimate aim is to develop diagnostic models that utilize non-invasive imaging data to enhance breast cancer diagnosis. This approach reduces subjective judgments in the diagnostic process, potentially improving diagnostic accuracy. It also provides valuable information for personalized treatment decisions, thus advancing the field of breast cancer treatment.
Detailed description
Breast cancer is one of the most prevalent cancers among women globally, and its increasing incidence poses a significant threat to women's health. Despite notable advances in early diagnosis and treatment due to the continuous progress in medical technology, the high heterogeneity within breast cancer still results in considerable variability in clinical manifestations, treatment responses, and disease progression. This diversity presents new challenges in achieving precise treatment. Thus, a profound exploration and study of the heterogeneity of breast cancer are crucial for developing more effective diagnostic models, advancing treatment strategies, and enhancing cure rates.
In current clinical practice, although biopsy is widely used for the diagnosis of benign or malignant breast tumors, its accuracy and comprehensiveness are somewhat limited due to the complex internal heterogeneity of breast cancer and the invasive nature of the procedure. In recent years, preoperative qualitative diagnosis of breast cancer using medical imaging technology has become a hot topic in research. Compared with other common imaging techniques such as CT and MRI, ultrasound examination is extensively employed due to its safety, convenience, and lower cost. Particularly, Contrast-Enhanced Ultrasound (CEUS) technology, with its superior temporal resolution, can vividly illustrate the details of tumor perfusion hemodynamics, effectively revealing key features such as enhancement patterns, blood supply, and vascular invasion of the tumor.
This study is dedicated to using dynamic CEUS videos to cluster perfusion characteristics at the pixel level within the tumor and divide the tumor into different subregions based on the clustering results. We will explore the correlation between these perfusion subregions and the diagnosis of benign or malignant breast tumors, and based on this, develop related diagnostic models. This non-invasive diagnostic approach aims to maximally mine and utilize image data, comprehensively capturing the tumor's perfusion characteristics at the pixel level, and reducing subjective judgments in the diagnostic process. The application of this method is not only expected to improve the accuracy of breast cancer diagnosis but also to provide more information support for personalized treatment of patients, thereby promoting progress in the field of breast cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign breast tumors | – | –Performing contrast-enhanced ultrasound on benign breast tumors and analyzing the video images |
| Malignant breast tumors | – | –Performing contrast-enhanced ultrasound on malignant breast tumors and analyzing the video images. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with breast nodule
Key inclusion criteria (3 listed)
- Prospective cohort patients voluntarily sign an informed consent form.
- Patients who undergo breast contrast-enhanced ultrasound.
- Patients with breast nodules that have not received any treatment.
Key exclusion criteria (5 listed)
- Patients who cannot obtain pathological results due to refusal of further diagnosis or treatment.
- Patients whose breast lesions are too large to display their long axis under the ultrasound probe.
- Patients contraindicated for contrast-enhanced ultrasound.
- Historical cohort patients who cannot obtain ultrasound contrast videos of at least 45-60 seconds post contrast agent injection.
- Patients whose ultrasound contrast videos show excessive motion displacement that cannot be corrected.
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
Accuracy
Time frame: 6 months
The proportion of breast tumors (benign or malignant) correctly classified by the diagnostic model.
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 10 Jan 2025.
- Individual participant dataSharing planned: No. The data cannot be shared because of ethical restrictions regarding human participant data.
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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 Tumor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 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: finished, as of the sponsor's last update on 10 Jan 2025. 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?
Accuracy (time frame: 6 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 10 Jan 2025; AzTrials last refreshed its copy on 30 Oct 2026.