Ultrasound Radiomics for Predicting Breast Cancer and Axillary Lymph Node Metastasis

NCT05768451 | Unknown

• 1 other identifier: 2022-YXZX-YX-08
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer; Axillary Lymph Node Metastasis

Keywords

breast cancer; multi-modal ultrasound; radiomics

Outcome Measures

Primary Outcomes (1)

• Accuracy of differential diagnosis between benign and malignant

  ROC curve, sensitivity, specificity, accuracy, decision curve

  2022.12.15-2023.12.30

Study Arms (2)

benign

Other: Ultrasonic image analysis

malignant

Other: Ultrasonic image analysis

Interventions

Ultrasonic image analysis OTHER

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.

benign; malignant

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Female patients with breast tumors
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

baojie wen, doctor

CONTACT

02583106666; 359408031@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: March 14, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: August 31, 2025
• Last Updated: March 14, 2023

Record last verified: 2023-03