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

Sponsor
West China Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05170282
Collaborator
(none)
200
1
35.9
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Radiomic Algorithm

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Deep Learning Magnetic Resonance Imaging Radiomics for Diagnostic Value of Hepatic Tumors in Infants
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Retrospective cohort

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.

Diagnostic Test: Radiomic Algorithm
Different radiomic, machine learning, and deep learning strategies for radiomic features extraction, sorting features and model constriction.

Prospective cohort

The same inclusion/exclusion criteria were applied for the same center prospectively. It is an external validation cohort.

Diagnostic Test: Radiomic Algorithm
Different radiomic, machine learning, and deep learning strategies for radiomic features extraction, sorting features and model constriction.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. The diagnostic sensitivity of infantile liver tumors with deep learning algorithm [1 month]

    The diagnostic sensitivity of infantile liver tumors with deep learning algorithm.

  2. The diagnostic specificity of infantile liver tumors with deep learning algorithm [1 month]

    The diagnostic specificity of infantile liver tumors with deep learning algorithm.

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Months to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age between newborn and 12 months

  • Receiving no treatment before diagnosis

  • With written informed consent

Exclusion Criteria:
  • Clinical data missing

  • Unavailable MRI images

  • Without written informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital, Sichuan University Chendu Sichuan China 610041

Sponsors and Collaborators

  • West China Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yuhan Yang, Doctor of Medicine, West China Hospital
ClinicalTrials.gov Identifier:
NCT05170282
Other Study ID Numbers:
  • HX2021-345
First Posted:
Dec 27, 2021
Last Update Posted:
Dec 27, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 27, 2021