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NCT05826197Not yet recruiting

Prediction of Axillary Lymph Node Metastasis Status in Breast Cancer Based on PET/CT Radiomics

A Study on the Construction of a Comprehensive Predictive Model for Axillary Lymph Node Metastasis in Breast Cancer
First Affiliated Hospital Xi'an Jiaotong UniversityClinicalTrials.govother
Study focus
Disease/Condition
Breast Neoplasms
Drug/Device/Intervention
Radiomics
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
First Affiliated Hospital Xi'an Jiaotong University
Timeline & enrollment
Phase
N/A
Start date
May 10, 2023
End date
Dec 01, 2024
Enrollment
100 participants
Primary outcome

Radiomics score

Summary

Patients with suspected breast cancer undergoing PET/CT at our hospital. The PET/CT center's
 chief physician and senior attending physician reviewed the films together and disagreement,
 if any, was resolved by consensus. The lesion was visually identified. A 3D region of
 interest(ROI) of the lesion was automatically outlined using the 40% threshold method, and
 PET metabolic parameters were measured . Breast lesions with radionuclide concentrations
 greater than those in normal breast tissue are considered to be breast cancer lesions, while
 lymph nodes with radionuclide concentrations greater than those in muscle tissue are
 considered to be metastatic lymph nodes.
 
 Image segmentation: Image segmentation was performed using ITK-SNAP software (4) (version
 3.6.0, http://www.itksnap.org/), Brush Style: circular, Brush Size: 10, Brush Options: 3D.
 The entire tumor volume was outlined on the PET image as ROI for segmentation.
 
 An open source Python package (PyRadiomics version 3.0.1(5)) was used to extract the
 radiomics features from the ROI.
 
 Univariate and multivariate binary logistic regressions were used to construct model for
 predicting lymph node metastasis in breast cancer.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastMalignant neoplasm: Breast, unspecifiedBenign neoplasm of breastMalignant neoplasm: Central portion of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05826197
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05826197 through Pure Global AI's free database. This phase not specified trial is sponsored by First Affiliated Hospital Xi'an Jiaotong University and is currently Not yet recruiting. The study focuses on Breast Neoplasms. Target enrollment is 100 participants.

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