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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06062173
Other study ID # wangyanbo
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 5, 2020
Est. completion date December 2024

Study information

Verified date June 2023
Source The First Hospital of Jilin University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In addition to kidney tumor specific factors, adherent perirenal fat is one of the most important causes of technical complications in kidney surgery, and currently, there is a lack of widely used non-invasive predictive models in clinical practice. In this study, a deep learning algorithm based on CT imaging and nomogram was proposed to identify and predict the presence of adherent perirenal fat. This study includes the construction of a prediction model based on CT imaging and the verification of the prediction model.


Description:

Importance: For patients with kidney tumors requiring surgical treatment, adhesive perirenal fat is a frustrating variable that surgeons encounter during surgery, but the current image-dependent kidney morphometric scoring system used to predict the potential difficulty of surgery ignores this factor. Accurate preoperative prediction of perirenal fat status remains an urgent need. Purpose: To determine whether radiomics features of perirenal fat derived from computed tomography images can provide valuable information for judging perirenal fat status, develop a prediction model based on CT radiomics combined with deep learning, and validate the performance of the model in an independent cohort. Design, setup and participants: The study included one retrospective dataset and one prospective dataset from four medical centers between January 2020 and September 2023. Kidney plain CT scan was performed in xx adult patients with partial nephrectomy or radical nephrectomy. The training set, validation set, and internal test set were provided by the First Hospital of Jilin University, and the external test set was provided by the First Hospital of Siping City, Liaoyuan Central Hospital and Dongfeng County Hospital. This diagnostic study used single-institution data from January 2020 to May 2023 to extract imaging omics features from the perirenal fat region (independent sample T-test, minimum absolute contraction, and selection operator logistic regression was used to screen for the best imaging omics features). Univariate and multivariate analyses of clinical variables in patients prior to renal surgery were performed to determine independent predictors of adherent perirenal fat in the clinical setting. Different classifiers were used to build prediction models using only the image-omics features and fusion prediction models using independent clinical predictors combined with the image-omics features. Its performance is verified in two test sets. Main achievements and measures: The discriminant performance of the image omics model was evaluated by the area under the receiver operating characteristic curve and confirmed by decision curve analysis.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date December 2024
Est. primary completion date March 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - (1)Renal tumors, patients requiring surgical treatment. (2) Patients with complete preoperative CT image data. Exclusion Criteria: -(1) Preoperative complications such as acute urinary tract infection, hydronephrosis, pulmonary infection, autoimmune disease, and blood system disease. (2) Severe respiratory movement artifacts in CT images. (3) Pregnant or breastfeeding women. (4) Patients who have received immunotherapy or chemoradiotherapy.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Yanbowang Ch'ang-ch'un Jilin

Sponsors (1)

Lead Sponsor Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiomics features Radiomics features related to the prediction of adherent perirenal fat. From January 2020 to December 2023.
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