To hear about similar clinical trials, please enter your email below
Trial Title:
Ultrasound Radiomics for Predicting Breast Cancer and Axillary Lymph Node Metastasis
NCT ID:
NCT05768451
Condition:
Breast Cancer
Axillary Lymph Node Metastasis
Conditions: Official terms:
Breast Neoplasms
Neoplasm Metastasis
Lymphatic Metastasis
Conditions: Keywords:
breast cancer
multi-modal ultrasound
radiomics
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Ultrasonic image analysis
Description:
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.
Arm group label:
benign
Arm group label:
malignant
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 subjectivity in the process
of clinical doctors in diagnosis and treatment, provide accurate, objective basis for
clinical decision making.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
Female
Gender based:
Yes
Gender description:
Female patients with breast tumors
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Start date:
April 1, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05768451
