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Trial Title:
Prediction of Axillary Lymph Node Metastasis Status in Breast Cancer Based on PET/CT Radiomics
NCT ID:
NCT05826197
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Lymphatic Metastasis
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Radiomics
Description:
PET Radiomics
Arm group label:
Axillary lymph node metastasis
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.
Criteria for eligibility:
Study pop:
Patients with breast cancer undergoing PET/CT at our hospital.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
-
1) 18F-FDG PET/CT for breast occupancy; 2) adult female patients with
pathologically confirmed breast cancer (age ≥18 years); 3) no history of
surgery, radiotherapy, or chemotherapy before 18F-FDG PET/CT; and 4) interval
between 18F-FDG PET/CT and puncture/surgery ≤2 weeks.
Exclusion Criteria:
-
1) multifocal, bilateral, or occult breast cancer; 2) incomplete clinical or
pathological data; 3) poor PET/CT image quality, when metabolic tumor
volume(MTV) cannot be automatically segmented; and 4) concomitant malignant
tumors.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Start date:
May 10, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Source:
First Affiliated Hospital Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05826197
