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

San Luigi Gonzaga Hospital

Status: Completed

Conditions: Carcinoma, Renal Cell; Kidney Neoplasms

Treatments: Other: 2D-PADUA nephrometric score; Other: 3D-PADUA nephrometric score

Study type: Observational

Funder types: Other

Identifiers

NCT05729763

8193 02 06 - 07 Jun 2019

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• four-phase (unenhanced, corticomedullary, nephrographic and urographic phases) contrast enhanced CT-scan

Exclusion criteria

• evidence of anatomical abnormalities, like horse-shoe shaped or ectopic kidney.
• preoperative imaging inadequate to perform a 3DVM (such as those with a CT-scan with >3 mm acquisition interval of the slices, or suboptimal difference of enhancement among the enhanced phases) or older than 3 months.

Trial design

300 participants in 1 patient group

Patients with localized renal tumor

Description:

Patients with localized renal tumor scheduled for minimally invasive partial nephrectomy in which 2D- and 3D-PADUA nephrometric score assessment was performed preoperatively

Treatment:

Other: 3D-PADUA nephrometric score

Other: 2D-PADUA nephrometric score