Ultrasound Radiomics for Predicting Breast Cancer and Axillary Lymph Node Metastasis

March 13, 2023 updated by: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: baojie wen, doctor
  • Phone Number: 53500 02583106666
  • Email: 359408031@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
benign
Other: Ultrasonic image analysis
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.
malignant
Other: Ultrasonic image analysis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of differential diagnosis between benign and malignant
Time Frame: 2022.12.15-2023.12.30
ROC curve, sensitivity, specificity, accuracy, decision curve
2022.12.15-2023.12.30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

August 31, 2025

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-YXZX-YX-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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