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The goal of this observational study is to build an intelligent ultrasound diagnostic system that integrates pathological typing, risk stratification and prognosis assessment. The main question it aims to answer is:
Neuroblastic tumors (NTs) represent the most common extracranial solid tumors in childhood, with the vast majority of patients diagnosed with neuroblastoma (NB)-the subtype associated with the highest malignancy and poorest prognosis. These cases present significant challenges in clinical diagnosis and management, often leading to unfavorable overall outcomes. Histopathological examination remains the gold standard for definitive diagnosis and classification. However, this method is invasive, carries a risk of complications, and its diagnostic accuracy is subject to operator experience and biopsy sampling location. Although medical imaging allows for noninvasive tumor assessment, it primarily relies on subjective visual interpretation by physicians, resulting in limited accuracy and reproducibility in distinguishing between different NT subtypes.
Radiomics, an emerging artificial intelligence-based imaging analysis approach, enables high-throughput extraction, analysis, and quantification of imaging features through automated algorithms, uncovering vast amounts of subvisual information. It has demonstrated considerable promise in the differential diagnosis, treatment evaluation, and outcome prediction of tumors. Current radiomics research on neuroblastoma is still in its early stages, with most studies focusing on modalities such as computerized tomography(CT), magnetic resonance imaging(MRI), and Positron Emission Tomography-Computed Tomography(PET-CT), while ultrasound-based radiomics investigations remain unexplored.
Ultrasonography, owing to its unique advantages-including absence of ionizing radiation, real-time dynamic imaging, operational convenience, and low cost-has become the preferred imaging modality for pediatric tumor screening and follow-up. Consequently, integrating radiomics with ultrasonography to develop an intelligent diagnostic system capable of noninvasively and accurately assessing NTs holds significant clinical value and translational potential. Such a system would facilitate precise preoperative classification, patient risk stratification, and support for clinical decision-making.
This study aims to construct and validate an intelligent ultrasound diagnostic system for pediatric neuroblastic tumors based on ultrasound radiomics features, as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| training set | The dataset from the Children's Hospital of Zhejiang University School of Medicine is planned to be randomly divided into a training set and an internal validation set in a ratio of 7:3. | ||
| internal validation set | The dataset from the Children's Hospital of Zhejiang University School of Medicine is planned to be randomly divided into a training set and an internal validation set in a ratio of 7:3. | ||
| independent external validation set | Data from the Children's Hospital Affiliated to Soochow University, Kunming Children's Hospital, and Anhui Provincial Children's Hospital were combined as an independent external validation set. |
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| Measure | Description | Time Frame |
|---|---|---|
| F1 score | F1 Score = 2 * (Precision * Recall) / (Precision + Recall) | Within one week after the model training is completed, calculations are conducted respectively on the internal validation set and the independent external validation set. |
| accuracy rate | Draw multi-class ROC curves and calculate based on the ROC curves. | Within one week after the model training is completed, performance tests are conducted respectively on the internal validation set and the independent external validation set. |
| specificity | specificity = (True negative cases / (True negative cases + False positive cases)) * 100% | Within one week after the model training is completed, calculations are conducted respectively on the internal validation set and the independent external validation set. |
| sensitivity | sensitivity= (True Positive / (True Positive + False Negative))*100% | Within one week after the model training is completed, calculations are conducted respectively on the internal validation set and the independent external validation set. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with NTs at the Children's Hospital of Zhejiang University School of Medicine, the Children's Hospital Affiliated to Soochow University, the Children's Hospital of Kunming City, and Anhui Provincial Children's Hospital from January 2015 to February 2025.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Children's Hospital | Hefei | Anhui | 230041 | China | ||
| The Children's Hospital Affiliated to Soochow University |
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| Suzhou |
| Jiangsu |
| 215008 |
| China |
| Kunming Children's Hospital | Kunming | Yunnan | 650100 | China |
| The Children's Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310000 | China |
| Wenling Institute of Medical Big Data and Artificial Intelligence | Wenling | Zhejiang | 317500 | China |