MedTrace Logo

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

NCT05729763 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-02-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • San Luigi Gonzaga Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05729763 on ClinicalTrials.gov