Clinical trial · Observational
Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2D-PADUA nephrometric score | Other | — | UNRESOLVED |
| 3D-PADUA nephrometric score | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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
- interventionNames
- Other: 3D-PADUA nephrometric score
- Other: 2D-PADUA nephrometric score
Primary outcomes (1)
- measure
- PADUA nephrometry score calculated via 3D virtual modelling and standard bidimensional CT scan images
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available