Clinical Trials Directory

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UnknownNCT05170282

Deep Learning Magnetic Resonance Imaging Radiomics for Diagnostic Value of Hepatic Tumors in Infants

Status
Unknown
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
West China Hospital · Academic / Other
Sex
All
Age
0 Months – 12 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTRadiomic AlgorithmDifferent radiomic, machine learning, and deep learning strategies for radiomic features extraction, sorting features and model constriction.

Timeline

Start date
2021-01-01
Primary completion
2023-12-31
Completion
2023-12-31
First posted
2021-12-27
Last updated
2021-12-27

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05170282. Inclusion in this directory is not an endorsement.