Deep Learning Magnetic Resonance Imaging Radiomics for Diagnostic Value of Hepatic Tumors in Infants
- Conditions
- HepatoblastomaHepatic Hemangioendothelioma
- Interventions
- Diagnostic Test: Radiomic Algorithm
- Registration Number
- NCT05170282
- Lead Sponsor
- West China Hospital
- Brief Summary
Hepatic tumors in the perinatal period are associated with significant morbidity and mortality in affected patients. The conventional diagnostic tool, such as alpha-fetoprotein (AFP) shows limited value in diagnosis of infantile hepatic tumors. This retrospective-prospective study is aimed to evaluate the diagnostic efficiency of the deep learning system through analysis of magnetic resonance imaging (MRI) images before initial treatment.
- Detailed Description
Hepatic tumors seldom occur in the perinatal period. They comprise approximately 5% of the total neoplasms of various types occurring in the fetus and neonate. Infantile hemangioendothelioma is the leading primary hepatic tumor followed by hepatoblastoma. It should be mentioned that alpha-fetoprotein (AFP) is highly elevated during the first several months after birth even in normal infants, thus the diagnostic value of AFP is limited for infantile patients with hepatic tumors. This study is a retrospective-prospective design by West China Hospital, Sichuan University, including clinical data and radiological images. A retrospective database was enrolled for patients with definite histological diagnosis and available magnetic resonance imaging (MRI) images from June 2010 and December 2020. The investigators have constructed a deep learning radiomics diagnostic model on this retrospective cohort and validated it internally. A prospective cohort would recruit infantile patients diagnosed as liver tumor since January 2021. The proposed deep learning model would also be validated in this prospective cohort externally. The established model would be able to assist diagnosis for hepatic tumor in infants.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Age between newborn and 12 months
- Receiving no treatment before diagnosis
- With written informed consent
- Clinical data missing
- Unavailable MRI images
- Without written informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Retrospective cohort Radiomic Algorithm The internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort. Prospective cohort Radiomic Algorithm The same inclusion/exclusion criteria were applied for the same center prospectively. It is an external validation cohort.
- Primary Outcome Measures
Name Time Method The diagnostic accuracy of infantile liver tumors with deep learning algorithm 1 month The diagnostic accuracy of infantile liver tumors with deep learning algorithm.
- Secondary Outcome Measures
Name Time Method The diagnostic sensitivity of infantile liver tumors with deep learning algorithm 1 month The diagnostic sensitivity of infantile liver tumors with deep learning algorithm.
The diagnostic specificity of infantile liver tumors with deep learning algorithm 1 month The diagnostic specificity of infantile liver tumors with deep learning algorithm.
The diagnostic positive predictive value of infantile liver tumors with deep learning algorithm 1 month The diagnostic positive predictive value of infantile liver tumors with deep learning algorithm.
The diagnostic negative predictive value of infantile liver tumors with deep learning algorithm 1 month The diagnostic negative predictive value of infantile liver tumors with deep learning algorithm.
Trial Locations
- Locations (1)
West China Hospital, Sichuan University
🇨🇳Chendu, Sichuan, China