NCT05729763

Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: San Luigi Gonzaga Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

STUDY DESIGN: prospective multicentric observational SAMPLE SIZE OF THE STUDY: The estimated number of patients to enroll in the multicenter study is at least 270 patients (statistically calculated referring to the results of a monocentric analysis including 101 patients with the same design, already performed by the Coordinator Center). NUMBER OF CENTERS INVOLVED: Considering a total number of patients enrolled of at least 270, number of Centers to be involved: 5. STUDY PROCEDURES: 3D virtual model rendering * CT-scan images sent in DICOM format to MEDICS (Turin, Italy) after anonymization. * Dedicated online platform available to upload the anonymized CT images, after registration. * CT imaging processing by bioengineers and 3DVM building within 72 hours * 3D-PDF download from the same online platform Nephrometric score assessment * All CT-scans and their 3DVMsevaluation in order to assess surgical complexity, as classified by the PADUA nephrometry score and its relative PADUA risk category. * For each Center: * assessment of the PADUA score on the basis of the CT-scans (2D-NS) by one urologist; * assessment of the PADUA score on the basis of the 3DVMs (3D-NS) by another urologist. Surgical intervention and pathological assessment * Dedicated expert surgeon for each Center performing NSS to all patients with the same surgical technique. * Dedicated uro-pathologist for each Center performing the histopathological evaluations of the specimens.

Conditions

• Kidney Neoplasms
• Carcinoma, Renal Cell

Interventions

Type	Name	Description
OTHER	3D-PADUA nephrometric score	Evaluation of the PADUA nephrometric score with 3D images
OTHER	2D-PADUA nephrometric score	Evaluation of the PADUA nephrometric score with 2D images

Timeline

• Start date: 2019-06-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2023-02-15
• Last updated: 2023-02-15

Locations

1 site across 1 country: Italy