Breast CancerNCT05768451
Ultrasound Radiomics for Predicting Breast Cancer and Axillary Lymph Node Metastasis
An observational study of Breast Cancer and Axillary Lymph Node Metastasis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
The project is proposed based on multimodal ultrasonic imaging omics building used for accurate prediction of the breast cancer and axillary lymph node metastasis load artificial intelligence forecasting model, this method can dig the hidden features of ultrasonic image is not visible to the naked eye, make up the… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer, Axillary Lymph Node Metastasis
- What is being tested?
- Ultrasonic image analysis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 31 Aug 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast tumors seen in Nanjing Gulou Hospital in September 2018 and later and confirmed by histological pathology were selected, and all patients had complete preoperative US, UE and CEUS examination data.
Who may be able to join
- patients who have not received breast puncture biopsy or neoadjuvant chemotherapy, etc. prior to ultrasonography;
- patients who are not allergic to the ultrasound contrast agent (SonoVue) and have signed an informed consent form for ultrasonography
- patients with breast tumors who have undergone surgical treatment at our hospital and have complete case histories.
Who cannot join
- patients with incomplete case data;
- cases with large breast masses that do not completely show the region of interest (ROI);
- patients who have undergone breast aspiration biopsy or other treatments such as neoadjuvant chemotherapy or endocrine therapy before ultrasound examination.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accurate Prediction of Breast Cancer and Axillary Lymph Node Metastasis Burden by Multi-modal Ultrasound-based Radiomics
The project is proposed based on multimodal ultrasonic imaging omics building used for accurate prediction of the breast cancer and axillary lymph node metastasis load artificial intelligence forecasting model, this method can dig the hidden features of ultrasonic image is not visible to the naked eye, make up the subjectivity in the process of clinical doctors in diagnosis and treatment, provide accurate, objective basis for clinical decision making.
- Conditions
- Breast Cancer, Axillary Lymph Node Metastasis
- Being tested
- Ultrasonic image analysis
- Keywords
- breast cancer, multi-modal ultrasound, radiomics
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic image analysisOther
Preoperative conventional ultrasound (US), elastic ultrasound (UE) and contrast-enhanced ultrasound (CEUS) images were analyzed. Histopathological results were used as the gold standard. The cases were randomly divided into training set and test set with a ratio of 7:3. The US image, UE image and CEUS image of the maximum long-axis section of each lesion were selected, and the region of interest (ROI) of the lesion was manually delineated.
| Study group | Role | What they receive |
|---|---|---|
| benign | Not described Receives: Other: Ultrasonic image analysis | |
| malignant | Not described Receives: Other: Ultrasonic image analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of differential diagnosis between benign and malignant
ROC curve, sensitivity, specificity, accuracy, decision curve
Measured: 2022.12.15-2023.12.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768451
- Sponsor's protocol ID
- 2022-YXZX-YX-08
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accurate Prediction of Breast Cancer and Axillary Lymph Node Metastasis Burden by Multi-modal Ultrasound-based Radiomics
- ClinicalTrials.gov ID
- NCT05768451
- Acronym / sponsor ID
- 2022-YXZX-YX-08
- Conditions
- Breast Cancer, Axillary Lymph Node Metastasis
- Keywords
- breast cancer, multi-modal ultrasound, radiomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 14 Mar 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 project is proposed based on multimodal ultrasonic imaging omics building used for accurate prediction of the breast cancer and axillary lymph node metastasis load artificial intelligence forecasting model, this method can dig the hidden features of ultrasonic image is not visible to the naked eye, make up the subjectivity in the process of clinical doctors in diagnosis and treatment, provide accurate, objective basis for clinical decision making.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benign | – | Other: Ultrasonic image analysis |
| malignant | – | Other: Ultrasonic image analysis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast tumors seen in Nanjing Gulou Hospital in September 2018 and later and confirmed by histological pathology were selected, and all patients had complete preoperative US, UE and CEUS examination data.
Key inclusion criteria (3 listed)
- patients who have not received breast puncture biopsy or neoadjuvant chemotherapy, etc. prior to ultrasonography;
- patients who are not allergic to the ultrasound contrast agent (SonoVue) and have signed an informed consent form for ultrasonography
- patients with breast tumors who have undergone surgical treatment at our hospital and have complete case histories.
Key exclusion criteria (3 listed)
- patients with incomplete case data;
- cases with large breast masses that do not completely show the region of interest (ROI);
- patients who have undergone breast aspiration biopsy or other treatments such as neoadjuvant chemotherapy or endocrine therapy before ultrasound examination.
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 |
|---|---|---|
| Ultrasonic image analysisPreoperative conventional ultrasound (US), elastic ultrasound (UE) and contrast-enhanced ultrasound (CEUS) images were analyzed. Histopathological results were used as the gold standard. The cases were randomly divided into training set and test set with a ratio of 7:3. The US image, UE image and CEUS image of the maximum long-axis section of each lesion were selected, and the region of interest (ROI) of the lesion was manually delineated. | Other | benign, malignant |
Primary outcome
Accuracy of differential diagnosis between benign and malignant
Time frame: 2022.12.15-2023.12.30
ROC curve, sensitivity, specificity, accuracy, decision curve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Axillary Lymph Node Metastasis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 3 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 baojie wen, doctor (02583106666 ext. 53500, 359408031@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of differential diagnosis between benign and malignant (time frame: 2022.12.15-2023.12.30). 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 Mar 2023.