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

NCT05729763 | Completed

• 1 other identifier: 8193 02 06 - 07 Jun 2019
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

minimally-invasive partial nephrectomy; nephrometry scores; 3D virtual imaging; HA3D; postoperative complications

Outcome Measures

Primary Outcomes (1)

• PADUA nephrometry score calculated via 3D virtual modelling and standard bidimensional CT scan images

  The PADUA nephrometry score predicts the risk of surgical and medical perioperative complications in patients who underwent partial nephrectomy. The PADUA nephrometry score evaluates different tumor characteristics: * Longitudinal (polar) location (Superior/inferior: 1pt; Middle: 2 pt), * Exophytic rate (\>=50%: 1pt; \<50%: 2pt; Endophytic: 3pt) * Renal rim (Lateral: 1pt; Medial: 2pt) * Renal sinus (Not involved: 1pt; Involved: 2pt) * Urinary collecting system (Not involved: 1pt; Dislocated/infiltrated: 2pt) * Tumor size (\<=4 cm: 1pt; 4.1-7 cm: 2pt; \>7: 3pt) The PADUA score, calculated as the sum of these parameters, stratify patients from PADUA 6 tumors, that have low risk of complications, to PADUA 14, with high risk of perioperative complications.

  Baseline

Secondary Outcomes (1)

• To compare the occurrence of postoperative complications, assessed by Clavien-Dindo classification

  90 days after surgery

Study Arms (1)

Patients with localized renal tumor

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

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

Interventions

3D-PADUA nephrometric score OTHER

Evaluation of the PADUA nephrometric score with 3D images

Patients with localized renal tumor

2D-PADUA nephrometric score OTHER

Evaluation of the PADUA nephrometric score with 2D images

Patients with localized renal tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with localized renal tumor scheduled for partial nephrectomy

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Luigi Gonzaga Hospital: lead

Study Sites (1)

San Luigi Gonzaga Hospital

Orbassano, TO, 10048, Italy

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell; Postoperative Complications

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 15, 2023
• Study Start: June 1, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

IT (1)