NCT06336499|Completed
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Sponsor study identifier
observational
600
0 countries
N/A
Study Start
January 1, 2012
Actual (reported)Primary Completion
October 31, 2022
Actual (reported)Study Completion
December 31, 2023
Actual (reported)Orbital tumors can be categorized into benign and malignant tumors, and there are significant variations in their biological behavior, treatment, and prognosis. This study aims to enhance the accurate diagnosis and risk stratification of orbital tumors using artificial intelligence (AI) technology and multiparameter magnetic resonance imaging (MRI) data. It further explores the intrinsic relationship between MRI and the differential diagnosis of benign and malignant orbital tumors, as well as the pathological subtypes of malignant tumors and Ki-67 expression levels. This research aims to aid in guiding personalized diagnosis and treatment decision-making for patients with orbital tumors while promoting the practical application and incorporation of AI technology.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2012
Actual (reported)October 31, 2022
Actual (reported)December 31, 2023
Actual (reported)March 22, 2024
Actual (reported)March 28, 2024
Actual (reported)The area under the curve of Receiver Operating Characteristic of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and levels of Ki-67 expression in malignant ones.
The area under the ROC curve is calculated by integrating the ROC curve, which plots Sensitivity against 1 - Specificity.
Pre-operation
The area under the Precision-Recall curve of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors.
Pre-operation
Sensitivity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors.
Pre-operation
Specificity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors.
Pre-operation
Accuracy of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors.
Pre-operation
Patients with malignant orbital tumors (lymphoma, melanoma, ...) diagnosed by pathological confirmation.
Patients with benign orbital tumors (cavernous hemangioma, inflammatory pseudotumor, ...) diagnosed by pathological confirmation.
Diagnosis models are established using quantitative features extracted from the multi-parametric MRI images and further processed by appropriate deep learning or machine learning algorithms.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients diagnosed with malignant or benign orbital tumors confirmed by pathology, who underwent multiparametric MRl (mp-MRl) at BeiiingTongren Hospital from 2015 to 2022, were included in this research. Otherwise, patients lacking a definitive pathological diagnosis or pre-operative multiparametric MRl (mp-MRl) were excluded from this investigation.
Junfang Xian, M.D., Ph.D.
Department of Radiology, Beijing Tongren Hospital, Capital Medical University
600 participants (actual enrollment reported by the registry).
First Submitted
March 22, 2024
First Posted
March 28, 2024
Study Start
January 1, 2012
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 31, 2022
Actual (reported)Study Completion
December 31, 2023
Actual (reported)Last Updated
March 29, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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