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Using Deep Learning Methods to Analyze Automated Breast Ultrasound and Hand-held Ultrasound Images, to Establish a Diagnosis, Therapy Assessment and Prognosis Prediction Model of Breast Cancer.

To Build and Evaluate a Precise Diagnosis, Therapy Assessment and Prognosis Prediction Model of Breast Cancer Based on Artificial Intelligence

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04270032
Enrollment
10000
Registered
2020-02-17
Start date
2020-02-01
Completion date
2024-09-01
Last updated
2022-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

The purpose of this study is using a deep learning method to analyze the automated breast ultrasound (ABUS) and hand-held ultrasound(HHUS) images, establish and evaluate a diagnosis, therapy assessment and prognosis prediction model of breast cancer. The model would provide important references for further early prevention, early diagnosis and personalized treatment.

Detailed description

1. Establishing a database By collecting ABUS, HHUS and comprehensive breast images data, essential information, clinical treatment information, prognosis, and curative effect information, a complete breast image database is constructed. 2. Marking ABUS images Three doctors use a semi-automatic method to frame the lesions on the image. 3. Building the model Using the deep learning method to preprocess, analyze and train the marked images, and finally get a model diagnosis, efficacy evaluation and prognosis prediction model of breast cancer. 4. Evaluating the model 1)Self-validation: Analyze the sensitivity, AUC of the breast cancer diagnosis model and the false-positive number on each ABUS volume. 2\) Compared the sensitivity, AUC and the false-positive number with a commercial diagnosis model. 3)To test the screening and diagnostic efficacy of computer-aided diagnosis systems through prospective or retrospective studies. 4)By analyzing the size and characteristics of the lesions after neoadjuvant chemotherapy, and predicting the OS and DFS time, the therapy assessment and prognosis prediction model were evaluated.

Interventions

DIAGNOSTIC_TESTABUS and HHUS

Using deep learning method to analyze and extract the features of automated breast ultrasound and hand-held ultrasound images

Sponsors

Seoul National University Bundang Hospital
CollaboratorOTHER
Xidian University
CollaboratorOTHER
Shenzhen University
CollaboratorOTHER
The First Affiliated Hospital of the Fourth Military Medical University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Female patients over 18 years old who come to the two centers for physical examination or treatment; 2. Complete basic information and image data

Exclusion criteria

1. There is no complete ABUS and HHUS images data; 2. The image quality is poor; 3. In multifocal breast cancer, the correlation between the tumor in the image and the postoperative pathological examination is uncertain.

Design outcomes

Primary

MeasureTime frameDescription
sensitivity4 yearsProportion of corrected-marked malignant lesions by the model
false-positive per volume4 yearsthe number of uncorrected-marked malignant lesions by the model
area under curve4 yearsarea under receiver operating characteristic (ROC) curve in percentage (%)
overall survival(OS) timeup to 10 yearsIt measures the time from the date of cancer diagnosis to any cause of death.
Disease-free survival (DFS) timeup to 5 yearsThe time that the patient is free of the signs and symptoms of a disease after treatment.

Countries

China

Contacts

Primary ContactHongping Song, MD
song.hp@foxmail.com86 029 84771663

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026