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
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.
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yan Li
- Phone Number: 0086-15829364429
- Email: 29396779@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Axillary lymph node metastasis
|
PET Radiomics
|
|
No axillary lymph node metastasis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiomics score
Time Frame: 1 day During the inspection
|
Higher radiomics scores indicate better model prediction performance
|
1 day During the inspection
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-YBSF-480
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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