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

Carcinoma, Renal Cell Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms

• NCT number: NCT05729763
• Study type: Observational
• Source: San Luigi Gonzaga Hospital
• Status: Completed
• Start date: June 1, 2019
• Completion date: September 30, 2022