- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06062173
Preoperative Prediction of Adherent Perirenal Fat. (APF)
Preoperative Prediction of Adherent Perirenal Fat Based on CT Radiomics Combined With Deep Learning: a Prospective, Multicenter Study.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Jilin
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Ch'ang-ch'un, Jilin, China, 130000
- Yanbowang
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Adherent perirenal fat group
The surgeon considers perirenal fat to be adherent.
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Non-adherent perirenal fat group
Perirenal fat is considered nonadherent by surgeons.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiomics features
Time Frame: From January 2020 to December 2023.
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Radiomics features related to the prediction of adherent perirenal fat.
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From January 2020 to December 2023.
|
Collaborators and Investigators
Investigators
- Principal Investigator: yanbo wang, The First Hospital of Jilin University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- wangyanbo
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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