Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiomics | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Axillary lymph node metastasis
- interventionNames
- Other: Radiomics
- label
- No axillary lymph node metastasis
Primary outcomes (1)
- measure
- Radiomics score
- timeFrame
- 1 day During the inspection
- description
- Higher radiomics scores indicate better model prediction performance
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDLi Y, Han D, Shen C. Prediction of the axillary lymph-node metastatic burden of breast cancer by 18F-FDG PET/CT-based radiomics. BMC Cancer. 2024 Jun 7;24(1):704. doi: 10.1186/s12885-024-12476-3. PMID 38849770
- DERIVEDLi Y, Han D, Shen C, Duan X. Construction of a comprehensive predictive model for axillary lymph node metastasis in breast cancer: a retrospective study. BMC Cancer. 2023 Oct 24;23(1):1028. doi: 10.1186/s12885-023-11498-7. PMID 37875818