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Prediction of Axillary Lymph Node Metastasis Status in Breast Cancer Based on PET/CT Radiomics - Trial NCT05826197

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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NCT05826197
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Trial Details
ClinicalTrials.gov โ€ข NCT05826197
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DJ Fang

DJ Fang

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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

Study Focus

Breast Neoplasms

Radiomics

Observational

other

Sponsor & Location

First Affiliated Hospital Xi'an Jiaotong University

Timeline & Enrollment

N/A

May 10, 2023

Dec 01, 2024

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 breast
Malignant neoplasm of breast
Malignant neoplasm: Breast, unspecified
Benign neoplasm of breast
Malignant neoplasm: Central portion of breast

Data Source

ClinicalTrials.gov

NCT05826197

Non-Device Trial